Total 5 Manager systems engineer job vacancies in Quality Assurance / Control category

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.

Responsibilities:

. Manage, maintain and continually improve the existing ISO 9001 / 14001 QMS, 13485 EMS and Business Excellence

(SQC)

. Scheduling and monitoring of QC Daily Inspection Work Plan.

· Responsible on the Corrective and Preventive Action relating to customer complaint.

· Responsible for generating of Work Instruction which deem required for Guiding QA Op.

· Ensure QA activities and operation is according to written procedures.

. Responsible for ensuring the completeness and free of error for OQC Inspection Report and First Article.

. Carry out the duty of Internal Auditor during QMS and EMS internal audit.

· Ensure QA/QC outgoing output is met to achieve production on time delivery

. Monitor and Evaluate Supplier Performance

. Coordinate with internal teams on investigation of customer complaint on product quality and internal non-

conformance, including corrective actions.

. Provide timely response to customer on quality matters including product quality complaint.

· Review on non-conformances & approve disposition actions.

. Handle customer claims, quality issues. Follow up closely with customers and the relevant department on all non-

conformances reports.

. Responsible for liaising with customers and suppliers on non-conformance activities as well as performing root

cause analysis and determining of the effective corrective actions to reduce or eliminate the cost of poor quality.

Requirements

. Candidate must possess at least Diploma/Advanced/Higher/Graduate Diploma, Bachelor's Degree/Post Graduate

Diploma/Professional Degree in Engineering / Quality Assurance Engineering (Others) or equivalent.

. At least 5 Year(s) of working experience in the related field is required for this position.

. Preferably Manager specialized in Quality Control/Assurance or equivalent.

Requirement:

• Proven working experience in test delivery or equivalent role with at least 10 to 15 years relevant experience in large and complex organizations preferably in the area of Banking and Finance and at least 5 years’ senior manager experience in testing. 
• Extensive experience in managing end to end delivery of testing services from multiple vendor test service providers. 
• Proven experience in testing standards, tools, processes & methodologies, frameworks, and various delivery methodologies e.g. Agile, Hybrid Agile and Waterfall, DevOps. 
• A proven, successful track record of managing shared IT service development and/ or IT Testing Services. 
• Demonstrated success in developing highly effective working relationships with internal and external stakeholders to deliver collaboration, partnerships and services. 
• Strong attention to details, excellent analytical and problem-solving skills. 
• Experience in managing multiple external testing service providers. 
• Experience in managing multi-cultural, diverse, direct and virtual teams.
• Must display a high level of professional judgment, commitment, integrity, and teamwork. 
• Excellent client facing, internal communications, written and verbal communication skills. 
• Testing or quality certifications, PMP certifications, ISTBQ and Test Maturity Model integration (TMMi) Framework awareness will be preferred.

Responsibilities:

• Overall accountable and responsible for delivery of testing services one or more applications and/or projects of Digital domain applications 
• Manage and oversee the day-to-day delivery of test services by appointed vendors in the conduct of testing · Works with the testing service providers and other stakeholders to review, provide feedback and sign off on the test strategy, test plans and other test service providers’ artefacts for the testing service delivery. 
• Coordinates with the Test Governance team to ensure adoption of testing methods, standards and tools, and to coordinate any health checks or audits. 
• Ensures that any changes to the scope of services are communicated to the respective test service providers and the impact is factored in to the plan.
• Engages with various stakeholders (including but not limited to, application, security, infrastructure, business), testing service providers to ensure testing services meet the objectives and demand.
• Act as the first point of escalation for any issues raised by stakeholders, testing service providers.
• Quantify, manage, track and report test related statuses, SLA and KPIs, and ensure that defined testing transformation SLA and KPI targets are met for the portfolio accountable. 
• Drive and collaborate with all stakeholders and test service providers to plan all testing related deliveries for the portfolio accountable. 
• Participate and contribute in forums, as required, to drive testing transformation and innovation. 
• Works closely with the Test Engineering Lead to provide inputs around domain specific test engineering requirements and ensure that they are met. 
• Establishes and maintains effective working relationships with the Vendor Test Managers/Test Leads for the respective domains. 
• Engages stakeholder communities to get their feedback on testing service delivery and identify improvement opportunities to be fed back to the Test CoE team.

Key Responsibilities

• Define and implement comprehensive test strategies, test plans, and testing processes & frameworks aligned with corporate guidelines and project objectives
• Establish and continuously improve testing processes, standards, and best practices
• Lead end-to-end test management across SIT, UAT, and other test levels/phases
• Drive test automation initiatives, including rollout and adoption of automation tools and frameworks
• Manage and mentor test teams, both onshore and offshore, providing leadership, supervision, and performance guidance
• Collaborate closely with business stakeholders, project managers, and technical teams to ensure alignment and delivery quality
• Ensure effective defect management, risk identification, and mitigation strategies
• Provide status reporting, metrics, and quality insights to senior management and stakeholders
• Oversee the implementation and optimization of test management tools and platforms

Requirements

• Diploma or Bachelor computer science or IT-related degree
• Minimum 12 years of experience in software testing
• Proven experience in test strategy, planning, and framework design
• Strong stakeholder management and communication skills across business and technical teams
• Demonstrated team leadership and supervisory experience
• Hands-on experience in test automation and/or test management tools implementation
• Strong understanding of SDLC, STLC, Waterfall and Agile methodologies
• Experience in banking or financial services domain is highly preferred
• Software testing certification such as ISTQB Certified Tester Foundation Level
• Strong advantage if candidate has experience with corporate banking systems
• such as:

• Oracle FlexCube (Core Banking)
• CGI T360 (Trade Finance)
• FIS ACBS (Lending Systems)

To lead and manage In-coming Quality, In-Process Quality Control, Final Quality Control and Assurance, Quality System, Quality Management OL, Physical Laboratory, Quality Service, and Business Analyst  (BA) Team to ensure that the processes are operated at an optimum level with regards to cost, quality, productivity, safety and machine uptime. Management Representative for the Quality Management System that include but not limited to ISO9001, ISO14001, OHSAS 18001, TS16949, AS9001, NADCAP and RBA.

• In-coming Quality, In-process Quality Control, Final Quality control and Assurance, Quality System, Physical Laboratory, and Quality Services

• To ensure that manpower for each sections are efficiently filled for smooth operations through proper manpower budgeting, and forecasting

• To supervise and carry out performance appraisal of direct reporting

• Setting of section level objectives / KPIs, which are in line with the company / corporate objectives / KPIs

• To operate effectively and efficiently the In-coming Quality, In-Process Quality Control, Final Quality Control and Assurance, Quality System, Physical Laboratory, and Quality Services operations and to ensure that all section level objectives / KPIs are met.

• To carry out overall planning to ensure that work, machine, manpower and processes can achieve high levels of capability and process control.

• To participate and guide the resolution of matters arising from In-coming Quality, In-Process Quality Control, Final Quality Control and Assurance, Quality System, Physical Laboratory, and Quality Services processes.

• To optimize the section’s operating costs by consistently implementing cost saving programs.

• To ensure all documents are in place and of updated revision.

• To ensure that procedures are followed and carried out as planned.

• To ensure that engineers and technicians are trained and qualified to perform their task. 

• To ensure engineers and technicians are constantly developed to their highest potential.

• To ensure that the 5S standard of housekeeping is consistently maintained.

• To implement quality program along the direction/criteria of SQA

• To ensure the BA team timely publish accurate reports for both Management/Corporate and customers, sales forecast analysis and as well as quarterly prepare business summary.

• To participate actively in improvement programs and other tasks assigned by his superior.

• Responsibilities with respect to significant aspects related link to operational control in work area.

• Any other duties as assigned
  

Job Requirements:

• Diploma and/or Degree in relevant areas.

• Minimum 10 years with management experience.

• Relevant working knowledge and technical experience in PCB manufacturing processes, especially in quality area

•  Possess strong leadership and interpersonal skills