Total 16,349 Full-time quality control engineer job vacancies

Responsibilities:

• Perform technical inspection services on vessels/shipyards/onshore marine/offshore facilities/anchorage/oversea job
• Prepare ship classification societies service reports and recommendation to customer after carrying out site inspection based on required industrial guidance/classification societies standards
• Liaise, organize, and execute the given task independently

Requirements:

• Diploma/Degree in Mechanical or Marine related field
• Those with ASNT/PCN NDT Level 2 certification in UT, UTG, MT, PT will be a plus
• At least 2 years in a similar capacity preferably in a marine industry
• Proficiency in MS Office and AutoCAD software
• Ability to multitask between projects and ability to work independently with minimum supervision
• Willing to work long hours and operationally ready
• Overseas travelling required
• Those with experience in hull structures of various vessels and Non-destructive testing knowledge will be advantage

Interested candidates, please send your detailed resume, stating the earliest availability to: HR Department [msmarine@singnet.com.sg]

Only shortlisted candidates will be notified.

School of Electrical and Electronic Engineering is one of the founding Schools of the Nanyang Technological University. Built on a culture of excellence, the School is renowned for its high academic standards and research. With over 3,000 undergraduates students and 2,000 graduate students it is one of the largest EEE schools in the world and ranks 4th in the field of Electrical & Electronic Engineering in the 2025 QS World University Rankings by Subjects.

Today, the School has become one of the world’s largest engineering schools that nurtures competent engineers and researchers. Each year, the School graduates over a thousand students who are ready to take on great ambitions and challenges.

For more details, please view: https://www.ntu.edu.sg/eee

We are looking for research assistants to conduct research in the areas of safety-critical control theory and machine learning. The role will focus on combining new theory or method in nonlinear system control and state-of-the-art machine learning systems, with applications to various robotic systems.

Key Responsibilities:

• Conduct research in the area of control theory and machine learning

• Conduct experiments on different robotic platforms

• International collaborations in the above areas

• Publish papers in related top journals and conferences

Job Requirements:

• Bachelor’s degree in control theory, machine learning, robotics, or related field

• Familiarity with nonlinear systems and control theory/state-of-the-art machine learning systems (diffusion, transformers, etc.)/robotics.

• Good written and oral communication skills

• Proficiency in programing (e.g., Python) and machine learning tools (e.g., PyTorch)

• Entry level candidates are welcome to apply

We regret to inform you that only shortlisted candidates will be notified.

• Position : Project Manager (Protection & Control Systems)
• Location : Alexandra
• Working hours : 5 Days Work Week – Monday to Friday: 8AM to 5PM / 8.30AM to 5.30PM / 9AM to 6PM / 9.30AM to 6.30PM / 10AM to 7PM
• Salary (commensurate with experience) : Up to $9,000 Basic + Midnight Allowance + OT + AWS + Performance Bonus (Up to 3 Months) + Medical Benefits ($500/year) with Dependents Coverage + 18 - 21 Days Annual Leave + Company Activities + Company Trips
• Duration : Perm
• Industry : Automation

Responsibilities:

• Manage multiple HV/MV protection systems projects from contract award to final handover, ensuring delivery meets project scope, timeline, budget, safety and quality requirements.
• Coordinate with clients, consultants, OEMs, system integrators and internal teams for FAT, SAT, protection testing, relay configuration, commissioning, energisation and substation integration.
• Prepare and monitor project execution plans, milestone schedules and look-ahead plans across engineering, procurement, configuration, installation, testing and commissioning stages.
• Track project costs, progress claims, variation orders and subcontractor claims to support profitability, cash flow and cost-to-complete forecasting.
• Serve as the main point of contact for clients and stakeholders, leading coordination meetings, providing progress updates and managing project expectations.
• Support management in technical clarifications, contract discussions, issue resolution and dispute management.
• Identify, monitor and manage project risks, including relay coordination issues, IEC 61850 configuration, communication/network integration and interface mismatches.
• Ensure compliance with company WSH policies, Singapore safety regulations, client/utility site rules and project quality standards.
• Coordinate internal handover from Sales to Project Delivery and work closely with engineering, procurement, installation and testing teams.
• Ensure proper project closeout, including as-built drawings, relay settings files, SCL files, commissioning reports and O&M manuals.

Requirements:

• Diploma/Degree in Electrical Engineering, Electronics Engineering or related discipline.
• Relevant experience in HV/MV protection systems, substation automation, switchgear, power automation or related electrical projects.
• Strong knowledge of protection relays, relay settings, wiring/logic diagrams, IEC 61850, RTUs, IEDs and SCADA/SAS systems.
• Experience managing FAT, SAT, testing, commissioning and energisation activities will be advantageous.
• Strong project management, stakeholder coordination, problem-solving and communication skills.
• Able to manage multiple projects independently and work under tight deadlines.

Email to: jeslyn@searchpersonnel.com.sg

Do visit www.facebook.com/search.personnel and https://www.instagram.com/search.personnel for more job listings and career tips!

***We do not charge our candidates any referral fee nor bind them with any contract.***

Jeslyn Tan

Deputy Consulting Director (APAC)

Reg no.: R21101247 | EA No: 13C6684

Our shortlisting process takes 3 working days, and only shortlisted candidates will be contacted.

If you do not hear from us within this period, your application was not shortlisted. We encourage you to continue your job search, and we will contact you should a suitable opportunity arise. We wish you all the best.

We are seeking a highly skilled and forward-thinking High-Level Control (HLC) / Operations Systems Manager to support mission-critical automated systems within a complex, high-availability operational environment.

This role plays a key part in ensuring the reliability, performance, and continuous improvement of real-time control systems that support large-scale operational flows in an airport environment, including baggage handling and related automation systems.

While experience in Baggage Handling Systems (BHS) is highly advantageous, we welcome candidates with strong backgrounds in industrial automation, mission-critical infrastructure, or large-scale control systems.

Key Responsibilities

1. System Operations & Reliability

• Manage and oversee operations and maintenance (O&M) contractors to ensure high availability and performance of high-level control systems.
• Ensure systems operate reliably in a 24/7 mission-critical environment.
• Monitor system health and proactively identify risks, performance degradation, and operational issues.

2. System Analysis & Improvement

• Analyse system and operational data to identify trends, risks, and improvement opportunities.
• Leverage analytics and monitoring tools to support performance optimisation.
• Drive continuous improvement initiatives for system stability, efficiency, and resilience.

3. Incident Management & Troubleshooting

• Diagnose and resolve network, software, and system issues in a timely manner.
• Lead root cause analysis for system incidents and implement preventive measures.
• Support operational continuity through effective incident response and recovery.

4. Projects & Technology Enhancement

• Lead and support system enhancement initiatives and technology upgrade projects.
• Manage end-of-life (EOL) and end-of-service (EOS) planning for hardware and software components.
• Define technical requirements, support procurement activities, and oversee vendor delivery.
• Participate in Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT).

5. Infrastructure, Network & Cybersecurity

• Ensure secure and stable operation of system networks and infrastructure.
• Work closely with cybersecurity teams and vendors to ensure compliance with security standards and regulatory requirements.
• Support implementation of cybersecurity controls and vulnerability management activities.
• Ensure adherence to ISO 27001 and critical infrastructure security practices.

6. Business Continuity & Risk Management

• Support and execute Business Continuity Plans (BCP) during system disruptions.
• Ensure minimal operational impact during incidents or system failures.
• Participate in risk assessments and resilience planning.

7. Stakeholder & Vendor Management

• Collaborate with internal stakeholders, vendors, and external partners.
• Manage the performance of outsourced maintenance and support providers.
• Ensure alignment between technical delivery and operational requirements

Requirements

Education & Experience

• Degree in Computer Science, Engineering, Information Technology, or related discipline.
• Minimum 5 years of experience managing enterprise IT infrastructure, industrial control systems, or mission-critical operational systems.
• Experience in airport systems, logistics automation, manufacturing control systems, or critical infrastructure environments is highly preferred.

Technical Skills

• Strong understanding of network infrastructure (TCP/IP, DNS, DHCP, VLANs, routing, switching).
• Experience with high-availability and resilient system architectures.
• Familiarity with system monitoring and performance management tools.
• Knowledge of industrial control concepts (SCADA, PLC, or equivalent systems) is a plus.
• Exposure to cybersecurity principles and compliance frameworks (e.g. ISO 27001, critical infrastructure standards).

Soft Skills

• Strong analytical and problem-solving capabilities.
• Ability to manage incidents under pressure in a 24/7 environment.
• Strong stakeholder and vendor management skills.
• Ability to manage multiple priorities and drive operational excellence.
• Good communication skills with both technical and non-technical stakeholders.

Candidates with experience in any of the following industries are encouraged to apply:

• Airport operations or baggage handling systems
• Logistics and warehouse automation
• Industrial automation and control systems
• Transportation systems (rail, ports, traffic systems)
• Data center or critical infrastructure operations

Role:

You will be facilitating immigration work, mainly on Singapore Permanent Resident and Singapore Citizenship applications. You will be responsible to develop and maintain the most up-to-date knowledge in Singapore inbound immigration regulations and policies to offer high-quality service to our clients with a keen eye for detail to perform with high work accuracy.

Responsibilities

• Manages immigration applications for clients relating to Singapore Citizenship and other applications etc

• Liaise effectively and work closely with clients on the required documents to ensure all documents are furnished for submission

• Advise clients on accurate documentation and provide advisory to them based on a deep understanding of Singapore inbound immigration regulations and policies

• Understand clients’ backgrounds and write cover letters to best present their profiles

• Ensure high work accuracy is delivered in all applications to the government bodies

• Provide exceptional customer experience and maintain high standards of service

• Attend to clients' queries and the completion of the formalities during and after post-submission within Company’s response time

• Updating and maintaining respective tracking sheets accurately in an organized and timely manner

• Any other duties assigned by Management

Requirements

• Minimally Diploma qualification in hospitality, mass communication, logistics or equivalent

• Strong communication skills with Chinese client and good written English skills

• Prior client management experience is required

• Preferably with at least 2 years of experience in customer facing & handling large volume of document . Client and project management experience is a plus

• No prior immigration experience is required as on-the-job training will be provided.

• Good time management skills & must be able to handle a high volume of digital documents

• Ability to plan workload and meet deadlines

Working hours:

Mon to Fri 9am - 6.30pm ( Hybrid Available )

Job Description

1. Quality Management System (ISO 9001)

- Maintain, implement, and improve the Quality Management System (QMS) in compliance with ISO 9001 requirements.

- Support internal and external audits, including preparation, execution, and closure of audit findings.

- Ensure proper documentation, control, and continuous alignment with regulatory and certification standards.

- Drive corrective and preventive actions (CAPA) for non-conformities identified through audits and process reviews.

2. Supplier Quality Management

- Develop and manage supplier quality programs to ensure incoming materials meet specifications.

- Perform supplier qualification, audits, and performance evaluations.

- Lead supplier corrective action requests (SCARs) and ensure timely resolution.

- Monitor supplier KPIs (e.g. defect rates, on-time delivery, quality performance).

- Collaborate with procurement / supply chain and engineering teams to address supplier-related issues and improvements.

3. Product & Process Quality Assurance

- Support new product introduction (NPI) activities including risk assessment (FMEA), control plans, and process validation.

- Conduct root cause analysis using tools such as 8D, Fishbone, 5 Why and Kepner-Tregoe methodology to resolve quality issues.

- Drive continuous improvement initiatives using Lean, Six Sigma, or similar methodologies.

- Ensure compliance with customer requirements, technical specifications, and industry standards.

4. Inspection & Testing

- Define and maintain inspection plans and quality criteria for incoming, in-process, and final inspection.

- Work with metrology and inspection teams to ensure accuracy and reliability of measurements.

- Ensure calibration and maintenance of inspection equipment.

5. Data Analysis & Reporting

- Analyze quality data to identify trends, risks, and improvement opportunities.

- Prepare regular quality reports and dashboards for management review.

- Support decision-making through statistical analysis (SPC, Cp/Cpk).

6. Cross-Functional Collaboration

- Work closely with engineering, production, procurement, and customers to resolve quality issues.

- Participate in customer audits and address customer complaints effectively.

- Provide quality training and guidance to internal teams and suppliers.


Requirements

- Bachelor’s Degree in Engineering (Quality, Mechanical, Manufacturing, or related field).

- Strong knowledge of ISO 9001 Quality Management Systems.

- Familiar with quality tools: FMEA, Control Plans, SPC, MSA, 8D, Lean/Six Sigma.

- Experience with supplier audits and quality performance management.

- Good understanding of precision machining processes and inspection techniques.

- Strong analytical and problem-solving skills.

- Excellent communication and stakeholder management abilities.

- Minimum 3–5 years of experience in quality engineering within a precision manufacturing or semiconductor environment.

- Proven experience in Internal and Supplier Quality Management.

- Lead Auditor certification for ISO 9001.

- Six Sigma Green Belt or equivalent certification.

- Certified Quality Engineer (CQE)

- Attention to detail and quality mindset

- Strong ownership and accountability

- Continuous improvement orientation

- Collaborative and proactive approach

- Ability to work in a fast-paced manufacturing environment

Join a leading Semi-Conductor Company as a Quality Supervisor to lead quality inspectors, ensure product quality standards, and support continuous improvement in a dynamic manufacturing environment.

Responsibilities

• Lead and supervise Quality Inspectors to achieve product quality, inspection standards, and production targets
• Monitor and manage quality activities across IQC, Assembly, Rack Build, Repair, Final QC, and Pack Out processes to prevent defects from reaching customers
• Support daily quality operations by preparing QC reports, handover reports, managing Golden Unit processes, and maintaining quality documentation
• Provide training, coaching, and cross-training to team members to enhance quality awareness and operational performance
• Collaborate with Production, Quality Engineering, and cross-functional teams to support new product introductions, rework activities, ESD control, and continuous improvement initiatives
• Ensure compliance with company procedures, safety standards, ISO requirements, and 5S housekeeping practices
• Work shifts as required, maintaining physical fitness and manual dexterity to stand for extended periods

Required competencies and certifications

• Minimum 2–3 years of leadership experience in manufacturing, quality, or production environments
• Proficient in Microsoft Office applications to maintain accurate reports and records

Preferred competencies and qualifications

• Good understanding of quality inspection processes, production operations, and defect control
• Strong communication, problem-solving, coaching, and teamwork skills
• Ability to work effectively in a fast-paced, dynamic environment with multitasking capability
• High school education or above preferred

We are seeking a Quality Manager to lead and maintain our quality management and calibration systems. The role oversees compliance with ISO/IEC 17025 and related standards, ensures the integrity of calibration and testing activities, and supports both technical and commercial functions. This is an onsite role based at our Tagore Lane facility.

Roles & Responsibilities

• Establish, implement and maintain the quality management system in line with ISO/IEC 17025 and applicable standards.
• Manage internal and external audits, including preparation, response and corrective/preventive action follow-up.
• Oversee calibration and testing processes to ensure technical competence, traceability and accuracy of results.
• Review and approve calibration reports and quality documentation.
• Maintain and improve laboratory procedures, records and environmental controls.
• Coordinate with vendors, customers and accreditation bodies on quality matters.
• Provide technical and quality support to the sales and operations teams.
• Train and guide staff on quality procedures and compliance requirements.

Requirements

• Degree or Diploma in a related field.
• 8 years of relevant working experience in quality management, calibration or laboratory operations.
• Working knowledge of ISO/IEC 17025 and quality systems / audit management.
• Good command of English for documentation, reporting and stakeholder communication.
• Strong attention to detail, organisational and problem-solving skills.

Role & Responsibility:

• Assist in the design, documentation, and implementation of internal control frameworks and processes to mitigate risks and ensure compliance with company policies and legal regulations.
• Execute periodic compliance and control testing to evaluate operational effectiveness, identifying gaps and proposing practical recommendations for improvement.
• Maintain and update internal control policies, procedures, and related documentation to ensure alignment with current business processes and regulatory changes.
• Support the Group Internal Audit team during reviews and investigations, and perform follow-up assessments to ensure audit recommendations are effectively implemented.
• Partner with process owners to develop, track, and drive corrective action plans, ensuring accountability for addressing identified control weaknesses.
• Serve as an internal control liaison with Finance, Legal, HR, and Operations to provide guidance, review SOPs, and ensure a consistent understanding of compliance requirements.
• Perform other job-related duties and special projects as assigned.

Requirements:

• At least 3 years related working experience, audit background is preferred but not compulsory;
• Bachelor degree in Business Administration, Management, Law, or a related field.;
• Candidate with Singapore CA, ACCA or other qualification body member is preferred;
• Excellent written and verbal communication skills;
• Strong problem-solving capabilities with a keen eye for detail and a "process-first" mindset.
• Proficient in Microsoft Office Suite. A proactive interest in AI applications for business (e.g., automation, generative tools for research/documentation) is highly desirable.
• Strong in project management skills will be an added advantage
• Willingness and ability to travel as required to various business units or regional offices on a project basis.

About the role

Pest Control Technician conducting pest control operations at residential, commercial, and industrial sites in Singapore.

Key responsibilities

• Conduct pest control operations at residential, commercial, and industrial sites

• Safely handle equipment and chemicals according to NEA guidelines

• Provide professional service and maintain good customer relations

• Report findings and complete service documentation

Requirements

• Must hold a valid Singapore Class 3 Driver's License

• NEA Pest Control Worker/Technician's License preferred but not required

• Singaporean

• Able to perform manual tasks and willing to work 5.5-day week

• Team player with a strong sense of responsibility

• No prior job experience needed

Benefits

• Progressive increase in salary after probation period

• Productivity bonus/incentives available

• Guaranteed long-term service bonus after every 5 years of employment

• All-rounded skills training provided

• Career progression opportunities

• Supportive team environment

IMMEDIATE POSITIONS!!

Responsible for inspecting properties, identifying pest infestations, and implementing effective pest control measures. Your role will involve treating infested areas, educating clients on prevention methods, and maintaining accurate records of services provided.

• Perform thorough inspections of properties to identify pest infestations
• Apply appropriate pest control methods, including the use of chemicals and traps
• Safely handle and apply pesticides according to established procedures
• Educate clients on effective pest prevention techniques and sanitation practices
• Document all services provided and maintain accurate records
• Respond promptly and professionally to client inquiries, concerns, and service requests
• Stay updated on the latest pest control techniques, products, and industry developments
• Adhere to company policies, industry regulations, and ethical practices

Requirements:

• For candidates without an NEA vector control license, a minimum "N level" passed in English, Maths plus one other subject is required, training will be provided
• Those attained Workplace Literacy & Numeracy (WPLN) Level 5 & above welcome to apply too
• Must be willing to do outdoor job
• Good team player and positive work attitude
• Excellent communication and customer service skills
• Mature candidates are welcome to apply

• Ensure consistent execution of quality inspection and testing activities while driving quality compliance, defect prevention, and continuous improvement through data-driven analysis and effective team supervision.
• Execute and supervise testing, inspection, and quality verification activities to ensure compliance with customer and operational requirements.
• Analyse quality data, defect trends, and performance metrics to identify improvement opportunities and drive corrective actions.

• Collaborate with Operations, Engineering, and customers to resolve quality-related issues and improve process performance.
• Lead root cause analysis investigations and support the implementation of corrective and preventive actions (CAPA).
• Maintain accurate quality records, reports, audit documentation, and product traceability.
• Conduct SOP, work instruction (WI), line setup, and qualification training to ensure operational compliance and capability.
• Support quality escalations, containment activities, and customer quality requirements.
• Monitor adherence to quality standards, procedures, and documentation requirements.

Requirements

• Diploma or Degree in Engineering, Quality Management, Supply Chain, or a related discipline.
• Approximately 5 years of experience in quality assurance, quality control, testing, inspection, or manufacturing operations.
• Strong knowledge of quality systems, inspection methodologies, and root cause analysis techniques.
• Strong communication, stakeholder management, and team supervision skills.
• Strong analytical skills with experience in quality reporting, data analysis, and performance monitoring.
• Proficiency in Microsoft Excel and quality reporting tools; experience with dashboards and data visualisation tools will be an advantage.
• Good understanding of SOPs, work instructions, audits, and quality documentation requirements.
• Work Location :Greenwich
• Salary Range $3,300 - $4,300
• Working Hours Mon – Fri, 0800 – 1745

JOB ID: GT/CARDSV0008

All Successful candidates can expect a very competitive remuneration package and a comprehensive range of benefits.

Kindly email your resume in a detailed Word format to gesse.tan@peopleprofilers.com

We regret that only shortlisted candidates will be notified

People Profilers Pte Ltd

• 20 Cecil Street, #08-09, Plus Building, Singapore 049705
• Tel: 69509745
• EA Licence Number: 02C4944
• EA Registration Number: R1108448
• EA Personnel: Tan Lili Gesse

• Location: North Singapore
• Office Hours, Monday – Friday
• Competitive Salary + AWS + Variable Bonus
• Medical Benefits Provided

About the role:
Join a global leader in the Life Sciences and Medical Technology industry. We are seeking a Quality Engineer to support quality assurance and continuous improvement initiatives across manufacturing, supply chain, and product development functions. This role offers the opportunity to work in a highly regulated environment and contribute to the quality and reliability of innovative scientific and healthcare products.

Job duties:

• Investigate product and system quality issues, perform root cause analysis, and recommend corrective actions.
• Support product testing activities by reviewing and evaluating test methods, protocols, and reports to ensure compliance with quality and regulatory requirements.
• Utilize statistical tools and data analysis techniques to drive quality improvements and support risk-based decision making.
• Collaborate with cross-functional teams to review engineering drawings, specifications, inspection plans, and manufacturing procedures.
• Establish critical quality characteristics and inspection requirements for components, sub-assemblies, and finished products.
• Drive continuous improvement initiatives using quality management tools and methodologies.
• Participate in product change control activities to ensure compliance with applicable quality and regulatory standards.
• Support risk management processes throughout the product lifecycle, including identifying, assessing, and mitigating quality risks.
• Monitor industry regulations, standards, and best practices relevant to medical devices and life science products.
• Contribute to quality system activities and support internal and external audits where required.

Job requirements:

• Bachelor's Degree in Engineering, Quality, Biomedical, Mechanical, Manufacturing, or a related scientific discipline.
• Minimum 3 years of experience in Quality Engineering within Medical Device, Life Sciences, Biotechnology, or regulated manufacturing environments.
• Knowledge of validation activities including Equipment Qualification (IQ/OQ/PQ) and process validation principles.
• Understanding of quality standards and regulations such as ISO 13485, ISO 14971, or FDA Quality System requirements will be advantageous.
• Experience with quality tools such as CAPA, FMEA, DOE, statistical sampling, and root cause analysis.

By submitting your resume, you consent to the collection, use, and disclosure of your personal information per ScienTec’s Privacy Policy (scientecconsulting.com/privacy-policy).

This authorizes us to:

Contact you about potential opportunities.
Delete personal data as it is not required at this application stage.
All applications will be processed with strict confidence. Only shortlisted candidates will be contacted.

Poh Tze Qi (Kayley) | R2197837
ScienTec Consulting Pte Ltd | 11C5781

• Ensure adherence to quality standards, regulations, and compliance with government, aviation authorities, and customer requirements.
• Liaise with customers, vendors, and suppliers to address non-conformances, conduct root cause analysis, and implement corrective actions.
• Conduct internal audits to assess the quality system, products, and processes (ISO9001, AS9100, NADCAP).
• Review and update quality procedures and control guidelines regularly.

Requirements:

• Degree in Mechanical, Aeronautical Engineering or equivalent.
• At least 5 years of experience with ISO9001/AS9100 QMS and NADCAP standards.
• Strong knowledge in fishbone diagrams, FMEA, and 5-whys analysis.
• Capable of reading and interpreting technical drawings.

If you are keen to apply for the position, kindly email your detailed resume in MS Word to hr@recruit-expert.com

Please note that only shortlisted candidates will be notified.

For more job opportunities, please visit our website at www.recruit-expert.com

EA Licence: 19C9701

Registration: R1326740

Job Description

Quality Management Systems / Quality Assurance Manager

Department:  Quality,Regulatory & Compliance
Location: Singapore
Reports to: Business Director
Employment Type:  Full-time, Permanent
Job Level: Manager / Senior Manager

About AITbiotech

AITbiotech Pte Ltd is aSingapore-based molecular diagnostics and bioinformatics company dedicated to advancing clinical decision-making through innovative genomic and diagnostic technologies. Our product portfolio — including abONE, abSEQ, abNEX, abGenix X,and abTES — serves clinicians and healthcare institutions across SoutheastAsia. We are committed to the highest standards of quality, safety, and regulatory compliance as we scale our operations and expand into new markets.

Role Overview

The QMS/QA Manager will be responsible for maintaining and continuously improving AITbiotech's Quality Management System in alignment with ISO 13485, HSA (Singapore MDA) regulations, and CE-IVD/IVDR requirements. This is a dual-focus role: ensuring our QMS operates robustly across all product lines while actively leveraging AI-assisted tools to modernise quality processes, documentation workflows, and regulatory intelligence. The successful candidate will be a pragmatic quality professional who understands both the regulatory landscape for in vitro diagnostics and the emerging potential of AI to enhance quality operations.

Key Responsibilities

1.  QMS Maintenance & Continuous Improvement

• Own and manage the end-to-end ISO 13485-certified QMS, including document control, change control, CAPA, internal audits, and management review processes.
• Conduct periodic QMS gap analyses, identify process weaknesses, and drive corrective and preventive action plans.
• Maintain and improve the Quality Manual, SOPs, work instructions, and related controlled documents across all departments.
• Lead internal audits and coordinate external/third-party audits; prepare audit responses and oversee closure of non-conformances.
• Foster a quality culture across the organization through training programmes and quality awareness initiatives.

2.  Regulatory Affairs & Certifications

• Manage and maintain regulatory submissions and product registrations with HSA (Singapore MDA) for IVD medical devices.
• Lead CE-IVD/IVDR compliance activities, including technical documentation, Declaration of Conformity, and liaison with Notified Bodies.
• Monitor changes to applicable regulations (ISO 13485, IVDR, HSA MDA, ASEAN AMDD) and assess impact on existing QMS and product registrations.
• Coordinate with external regulatory consultants and legal counsel on cross-border market access strategies in Southeast Asia and beyond.
• Support product development teams with regulatory input during design and development, risk management (ISO14971), and design verification/validation activities.
• Manage post-market surveillance activities including complaint handling, vigilance reporting, and periodic safety update reports.

3.  AI Integration in Quality Operations

• Identify and pilotAI-assisted tools for QMS functions including intelligent document management, automated non-conformance tracking, audit trail analysis, and regulatory intelligence monitoring.
• Collaborate with IT and bioinformatics teams to evaluate and deploy AI/ML solutions that improve quality data analysis, risk assessment, and complaint trending.
• Develop validation frameworks and procedures for AI tools used in quality-critical processes, ensuring compliance with applicable standards.
• Stay current with industry guidance on AI use in regulated medical device environments (e.g., FDA AI/ML guidance, IMDRF frameworks) and translate into internal policies.
• Champion responsible AI adoption within the quality function — balancing efficiency gains with regulatory traceability and auditability requirements.

4.  Supplier & Partner Quality

• Qualify and periodically audit critical suppliers and contract manufacturers; manage approved supplier lists.
• Review and negotiate Quality Agreements with suppliers, distributors, and contract service providers.
• Manage OEM partner quality interfaces, ensuring incoming product quality and supply chain compliance.

5.  Cross-functional Collaboration

• Partner with R&D, operations, sales, and commercial teams to embed quality requirements into new product introduction and product lifecycle management.
• Provide QA sign-off for batch releases, labelling reviews, and product changes.
• Represent the quality function at senior leadership level; produce quality KPI dashboards and trend reports.

Qualifications & Experience

Essential

• Bachelor's degree or higherin Life Sciences, Biomedical Engineering, Molecular Biology, or a relateddiscipline.
• Minimum 5 years of experiencein Quality Assurance/QMS roles within a regulated medical device or IVDenvironment.
• Demonstrated working knowledge of ISO 13485:2016 and hands-on experience maintaining or auditing a certified QMS.
• Practical experience with HSA (Singapore MDA) IVD product registration processes.
• Solid understanding of CE-IVD/IVDR requirements, technical file structure, and conformity assessment pathways.
• Proficiency in CAPA management, risk management (ISO 14971), and non-conformance investigation methodologies.
• Strong documentation skills with meticulous attention to detail.
• Excellent communicator with the ability to engage regulators, auditors, and internal stakeholders at all levels.

Preferred

• Postgraduate qualification in Regulatory Affairs, Quality Management, or equivalent.
• Certified Quality Auditor(CQA, IRCA, or equivalent) or ISO 13485 Lead Auditor certification.
• Experience in next-generationsequencing (NGS), molecular diagnostics, or genomics-based IVDs.
• Exposure to ASEAN regulatory frameworks (e.g., BFAD Philippines, NPRA Malaysia, TFDA Taiwan).
• Hands-on experience with AI/automation tools applied to quality or regulatory processes (e.g., AI-driven document review, intelligent CAPA platforms, regulatory intelligence software).
• Familiarity with electronic QMS (eQMS) platforms such as Veeva Vault QMS, Master Control, or Qualio.
• Experience in startup or scale-up environment with the ability to operate independently and build processes from limited infrastructure.

Core Competencies

• Regulatory Acumen — deep understanding of IVD regulatory frameworks and ability to translate requirements into actionable QMS controls.
• Analytical Thinking —data-driven approach to quality problem solving, root cause analysis, and trend identification.
• AI Curiosity &Adaptability — genuine interest in applying AI/ML tools to regulated quality environments, with a compliance-first mindset.
• Cross-functional Influence —ability to influence without authority across R&D, operations, and commercial teams.
• Ownership & Initiative —self-directed and proactive; comfortable operating in a fast-moving scale-up environment.
• Audit Readiness — confident representing the company during regulatory inspections and stakeholder briefings.