Summary

The Manager/Senior Manager, Quality Assurance & Regulatory Affairs (QA/RA) will be responsible for establishing, implementing, and maintaining a compliant and robust Quality Management System (QMS) in accordance with ISO 13485, EU MDR2017/745, and FDA 21 CFR Part 820 (QMSR).

This role will lead Quality Assurance (QA), Quality Engineering (QE), and Regulatory Affairs (RA) functions to support the development and manufacturing of Class III implantable medical devices, including pericardial patches and biological heart valves.

The position will play a critical role in ensuring regulatory compliance, product quality, and successful market access (CE mark and FDA approval).

Responsibilities

·       Lead and support the development and execution of regulatory strategies for CE marking and FDA submissions.

·       Lead and facilitate regulatory inspections, including Notified Body audits and FDA Pre-Approval Inspections (PAI).

·       Drive quality engineering initiatives, including process validation, risk management, processo ptimization, and continuous improvement.

·       Oversee key quality systems, including CAPA, internal audits, complaint handling, and supplier quality management.

·       Collaborate cross-functionally with Engineering, Manufacturing, and R&D, and act as the management representative for quality and regulatory compliance.

·       Establish and maintain the Quality Management System documentation, including the Quality Manual, SOPs, document control, and records management.

Requirements

·       Bachelor’s degree or higher in Biomedical Engineering, Life Sciences, Chemical Engineering, or a related discipline.

·       Minimum 10 years of relevant experience in the medical device or pharmaceutical industry, including at least 5 years in a leadership capacity.

·       In-depth knowledge of FDA 21 CFR Part 820, EU MDR2017/745, ISO 13485, and ISO 14971.

·       Familiarity with industry standards such as ISO 14644 (cleanroom manufacturing), ISO 10993, and ISO 5840 would be advantageous.

·       Proven experience in regulatory submissions (CE Mark and FDA) for Class III implantable medical devices is highly preferred.

·       Demonstrated strong leadership and team-building capabilities, with the ability to operate effectively in a start-up or greenfield environment.

·       Excellent communication and stakeholder management skills, with the ability to engage senior management, regulatory authorities, and external partners.

·       Strategic mindset with hands-on execution capability, coupled with a high level of accountability and attention to detail.

What you'll be doing

• Developing and implementing effective quality control processes and procedures

• Conducting thorough inspections and testing of raw materials, work-in-progress, and finished products

• Analyzing data and generating reports to identify and address quality issues

• Collaborating with production and engineering teams to improve manufacturing processes

• Ensuring compliance with industry standards, regulations, and the company's quality management system

• Training and mentoring junior quality assurance personnel

• Continuously seeking ways to enhance quality and efficiency

What we're looking for

• Diploma / Degree in Mechanical Engineering or a related field

• Min 2 years of experience as a QA Engineer in the precision engineering or machining industry

• Experience in NADCAP processes is an advantage

• Excellent knowledge of quality control principles, methodologies, and best practices

• Strong technical aptitude and hands-on experience with a variety of testing and measurement equipment

• Proficiency in data analysis and report generation using relevant software tools

• Problem-solving and critical thinking skills to identify and resolve quality issues

• Excellent communication and interpersonal skills to collaborate effectively with cross-functional teams

Interested applicants, please click on “Apply Now” or submit your resume to ref68@trustrecruit.com.sg

We regret only shortlisted candidates will be notified.

Important Note: Trust Recruit Pte Ltd is committed to safeguarding your personal data in accordance with the Personal Data Protection Act (PDPA).

Please read our privacy statement on our corporate website www.trustrecruit.com.sg 

Trust Recruit Pte Ltd

EA License No: 19C9950

EA Personnel: John Angeline

EA Personnel Reg No: R1544851

As a Freelance Quality Control Inspector, you'll be reporting to an Operations Manager /and working as a part of our Operations team. At QIMA, the role of Operations is to deliver our industry-leading services to our clients while ensuring that all the work is performed to the QIMA standard of quality. Your role in this will be to:

• Check email daily in order to receive inspection documents and guidelines;
• Attend inspections on time and communicate with supplier in a professional way;
• Perform the inspection of the merchandise according with company procedures. Supervise the stuffing of the containers according with company procedures;
• Fulfill inspection reports according with company procedures and time lines.

Job Description

• Industry/ Organization Type: Education
• Position Title: Quality Assurance Executive
• Working Location: Central (near Raffles MRT)
• Working Hours: 5 Days, Mon – Fri (8am – 5pm)
• Salary Package: Basic Salary + Performance Bonus
• Duration: Permanent

Key Responsibilities

• Monitoring and auditing internal processes to ensure alignment with EduTrust and SSG regulations.
• Collecting, analyzing, and interpreting data on student outcomes, satisfaction levels, and key performance indicators.
• Identifying gaps and opportunities for improvement and collaborating with staff to implement effective solutions.
• Maintaining accurate QA documentation and preparing timely reports for management and accreditation bodies.
• Promoting a culture of excellence and continuous improvement across teaching, learning, and operations.
• Other required duties as assigned.

APPLY NOW!!!

• Minimum Diploma in Education, Business, Quality Management, or related discipline.
• Knowledge of EduTrust standards and SSG regulatory frameworks is an added advantage.
• Excellent analytical and communication skills.
• Candidates without experience are welcome to apply, training will be provided.

Kindly apply through ANY of the following methods:

• Submit your application by clicking the APPLY button;
• Email your resume to Job@anradus.com.sg. Please indicate #78601 on the email subject.

Anradus Application Policy: We value each application and ensure every resume is reviewed. Our process is efficient, typically concluding within 3 working days. If you do not receive communication from us within this timeframe, it's likely that your application has not been shortlisted by our client. In such cases, we recommend continuing your job search to maximize your opportunities.

Anradus Pte Ltd | EA License No. 20C0161 | Angel Lim | EA Reg No.: R1769781

- Obtain immediate containment, root cause and corrective action(s) on defects discovered at incoming inspection / manufacturing floor.

- Work closely with Buyers and Vendors to close out defect cases

- Drive internal corrective action with immediate disposition for defects deemed responsibility.

- Drive continuous improvement throughout supply base to meet quality and corporate goals.

- Perform supplier assessments and audits as required by audit plans.

- Guide new vendors and enforcing requirements to meet world class Quality standards

- Provide presentation materials for the following meetings: Board of Directors, Quality, Supplier and Manufacturing.

- Hold Quality Performance Review with vendors

- Make MRB decisions and drive immediate actions by working with responsible engineers.

- Responsible for measuring and hiting all inspection metrics including incoming defect rate,

ship to stock rate, inspection backlog and SCAR metrics.

- Responsible for Quality performance to Goals 5S/Safety requirements.

- Responsible for departmental compliance to division’s ISO9000 Quality System and all associated procedures, including engineering drawings, assembly and test procedures, etc.

- Responsible for the assessment, development and execution of inspection schedules in accordance with company requirements

- Manage safety reporting for the department.

- Well versed in inspection techniques in order to perform first article inspections and production validation of piece part components and assemblies during source inspection

- Familiar with inspection equipment from vernier to complex CMM layout inspection to perform source inspection at vendor’s site where necessary

- Electrical / electromechanical experience preferred

- Experience in driving quality improvement for mechanical commodities such as machining, sheet metal, frames or consumables

- Experience in driving quality improvement for electrical commodities such as PCBA, box build, cable & harness

- Able to interpret complex mechanical & electrical drawings and geometric tolerancing

Interested candidates, please email your resume to annasee@recruitexpress.com.sg

Anna See Sing Yee

CEI Reg R25157535

Recruit Express Pte Ltd

EA License No: 99C4599

We regret that only shortlisted candidates will be contacted

Job Description

• Industry/ Organization Type: Education
• Position Title: Quality Assurance Executive
• Working Location: Central (near Raffles MRT)
• Working Hours: 5 Days, Mon – Fri (8am – 5pm)
• Salary Package: Basic Salary + Performance Bonus
• Duration: Permanent

Key Responsibilities

• Monitoring and auditing internal processes to ensure alignment with EduTrust and SSG regulations.
• Collecting, analyzing, and interpreting data on student outcomes, satisfaction levels, and key performance indicators.
• Identifying gaps and opportunities for improvement and collaborating with staff to implement effective solutions.
• Maintaining accurate QA documentation and preparing timely reports for management and accreditation bodies.
• Promoting a culture of excellence and continuous improvement across teaching, learning, and operations.
• Other required duties as assigned.

APPLY NOW!!!

• Minimum Diploma in Education, Business, Quality Management, or related discipline.
• Knowledge of EduTrust standards and SSG regulatory frameworks is an added advantage.
• Excellent analytical and communication skills.
• Candidates without experience are welcome to apply, training will be provided.

Kindly apply through ANY of the following methods:

• Submit your application by clicking the APPLY button;
• Email your resume to Job@anradus.com.sg. Please indicate #78601 on the email subject.

Anradus Application Policy: We value each application and ensure every resume is reviewed. Our process is efficient, typically concluding within 3 working days. If you do not receive communication from us within this timeframe, it's likely that your application has not been shortlisted by our client. In such cases, we recommend continuing your job search to maximize your opportunities.

Anradus Pte Ltd | EA License No. 20C0161 | Angel Lim | EA Reg No.: R1769781

Job Description:

• Work as a team to create and implement comprehensive quality assurance plans that outline the processes and procedures for ensuring quality throughout the product lifecycle, from design to manufacturing to delivery.
• Conduct internal and external audits to assess the effectiveness of quality control procedures and identify areas for improvement.
• When quality issues are identified, work to determine the root cause of the problem, develop corrective actions, and monitor their implementation to ensure they are effective.
• Ensure that company's products and services meet relevant industry standards and regulations, including standards like NADCAP.
• Provide training and awareness programs for employees on quality control procedures and best practices.
• Actively participate in continuous improvement projects to enhance quality and reduce costs.
• Collaborate with suppliers to ensure that their products and services meet the required quality standards.

Requirement:

• Min Degree in Engineering
• Min 3 years of experience in certifying staff and lead QA activities

To submit your application, please apply online apply@rn-care.com or call +(65) 6513 5697 for private and confidential discussion.

Your interest will be treated with the strictest of confidence. We regret that only shortlisted candidates will be notified or contacted.

RN Care Pte. Ltd
EA License No: 17C8900

Job Description:

• Work as a team to create and implement comprehensive quality assurance plans that outline the processes and procedures for ensuring quality throughout the product lifecycle, from design to manufacturing to delivery.
• Conduct internal and external audits to assess the effectiveness of quality control procedures and identify areas for improvement.
• When quality issues are identified, work to determine the root cause of the problem, develop corrective actions, and monitor their implementation to ensure they are effective.
• Ensure that company's products and services meet relevant industry standards and regulations, including standards like NADCAP.
• Provide training and awareness programs for employees on quality control procedures and best practices.
• Actively participate in continuous improvement projects to enhance quality and reduce costs.
• Collaborate with suppliers to ensure that their products and services meet the required quality standards.

Requirement:

• Min Degree in Engineering
• Min 3 years of experience in certifying staff and lead QA activities

To submit your application, please apply online apply@rn-care.com or call +(65) 6513 5697 for private and confidential discussion.

Your interest will be treated with the strictest of confidence. We regret that only shortlisted candidates will be notified or contacted.

RN Care Pte. Ltd
EA License No: 17C8900

Funding Societies is the largest unified SME digital loans platform in Southeast Asia. It is licensed and registered in Singapore, Indonesia, Thailand, Malaysia, and operating in Vietnam. The FinTech company provides THB35 billion annually in business loans to small and medium-sized enterprises (SMEs).

In Thailand, we operate under a debt-crowdfunding license granted by the Securities and Exchange Commission (SEC) and also provide direct lending services to SMEs. Our mission is to uplift societies in Southeast Asia by creating financial opportunities for everyone. We are committed to solving the SME financing gap in the region while providing convenient and short-term fixed-income investment options to individuals and institutions.

We are in search of a Compliance who will oversee all business and operations relating to Compliance including policies, investments, and procedures for Thailand, and supporting Compliance related activities across other SEA countries. He/She will assist, develop and implement company policies and procedures including enterprise-wide risk management, fit and proper checks, business continuity management and outsourcing framework.

What you will do:

• Subject matter expert on AML/CFT and KYC issues
• Manage information requests and liaison communication with the SEC and other government agencies
• Design, evaluate, maintain internal policies, and coordinate with different department managers to help shape the company's approach on Compliance and related matters
• Regularly assess the efficiency of control systems and recommend improvements.
• Review, evaluate and audit company procedures and reports to identify hidden risks or common issues.
• Lead employee training sessions on compliance issues.
• Perform compliance review on outsourcing vendors.
• Maintain various compliance and regulatory registers

What we are looking for:

• Bachelor’s degree in law, business administration, or relevant field.
• A minimum of 3-5 years’ experience as a compliance officer, or similar position.
• Strong knowledge of industry processes and regulations.
• Outstanding communication and interpersonal abilities.
• An analytical mindset with excellent organizational skills
• Fintech related compliance experience preferred

• Time off - We would love you to take time off to rest and rejuvenate. We offer flexible paid vacations as well as many other observed holidays by country. We also like to have our people take a day off for special days like birthdays and work anniversaries.
• Flexible Working - We believe in giving back the control of work & life to our people. We trust our people and love to provide the space to accommodate each and everyone's working style and personal life.
• Medical Benefits - We offer health insurance coverage for our employees. Our people focus on our mission knowing we have their back for their loved ones too.
• Mental Health and Wellness - We understand that our team productivity is directly linked to our mental and physical health. Hence we have Wellness Wednesdays and we engage partners to provide well-being coaching. And we have our Great FSMK Workout sessions too to keep everyone healthy and fit!
• Learning & Development - We believe learning should never end and we support everyone with self-learning L&D allowances.
• Tech Support - We provide a company laptop for our employees and the best possible support for the right equipment/tools to enable high productivity

Interested to know more about us? Learn about our Stories here.

Jobscope

• Revise and review Standard Operating Procedures (SOPs)
• Review executed Manufacturing Batch Record (MBR)/Electronic Manufacturing Batch Record (EBR) and Batch Release
• Support manufacturing team with any quality interpretation, queries and issues
• Provide quality oversight (participate GEMBA walk, GMP Walk)
• Perform archival of Quality Operation related documents
• To support Quality operational tasks (such as Improvements project for Batch release)

Requirements

• Experience in a GMP-regulated pharmaceutical or biologics manufacturing environment.
• Demonstrated knowledge of Good Documentation Practices (GDP) and current Good Manufacturing Practices (cGMP).
• Strong attention to detail, with the ability to interpret and apply quality standards accurately.

All qualified applicants, please send in your resume to:

triciagoh@recruitexpress.com.sg

Tricia Celestine Goh (R1981653)

Recruit Express Pte Ltd | Company Reg. No. 199601303W | EA License Number: 99C4599

Responsibilities

·               Developand drive a strategic roadmap for yield improvement and defect reduction acrosscritical process modules.

·               Leadthe design and maintenance of advanced, real-time Statistical Process Control(SPC), Fault Detection and Classification (FDC), and Advanced Process Control(APC) systems to stabilize and optimize all fabrication steps.

·               Cross-contaminationmanagement to achieve balance between research and development flexibilities inintegration runsheet flow path vs process tools health and processrepeatability.

·               Smallvolume prototype protocol and product and process control plan alignment andset-up with requestor, process margin runs till demonstration of product SPCrepeatability and line defect and electrical yield.

·               Serveas the technical expert and primary quality interface for key customers,leading customer audits, addressing quality-related concerns, and drivingcustomer-specific quality improvement plans.

·               Directand oversee high-level, cross-functional root-cause analysis (RCA) andcorrective and preventive action (CAPA) teams for major process excursions,non-conformances, and field returns, utilizing methodologies like 8D or SixSigma

·               Overseethe selection, qualification, and maintenance of all in-line and off-linemetrology and defect inspection tools, ensuring measurement system accuracy(Gage R&R) and high data quality.

·               Collaboratewith Process Integration and R&D teams to define, qualify, and stabilizerobust manufacturing process windows for all new product introductions (NPI),ensuring Design for Manufacturability (DFM) principles are met.

·               Leveragelarge-scale manufacturing data (Big Data) to identify subtle process drifts,predict failures, and proactively implement controls.

·               Lead,mentor, and manage a team of Quality Engineers, Process Control Engineers, andTechnicians, setting performance goals, developing career paths, and fosteringa culture of ownership and data-driven decision-making.

·               Collaborateclosely with all stakeholders to balance the trade-off between qualitystability, process efficiency, and tool uptime.

Requirements

·               Degreein Engineering, Materials Science, Chemical Engineering, or a related technicalfield.

·               Preferable10+ years of experience in the semiconductor industry, with a minimum of 5years in a leadership/management role focusing on Process Control, QualityAssurance, or Yield Engineering within a Fab environment.

·               Technicalknowledge of semiconductor fabrication processes in different modules.

·               Expert-levelknowledge of Statistical Process Control (SPC), Design of Experiments (DOE),Failure Mode and Effects Analysis (FMEA), and Lean/Six Sigma methodologies(Black Belt certification highly preferred).

To find out more about thisopportunity, please contact Lionel Liew atlionel.liew@gmprecruit.com.

We regret that only shortlisted candidates willbe notified.

GMP Technologies (S) Pte Ltd  |   EA Licence: 11C3793|   EA Personnel: Lionel Liew   |  Registration No: R1330693

This is in partnership with the Employment andEmployability Institute Pte Ltd (“e2i”).

e2i is the empowering network for workers andemployers seeking employment and employability solutions. e2i serves as abridge between workers and employers, connecting with workers to offer jobsecurity through job-matching, career guidance and skills upgrading services,and partnering employers to address their manpower needs through recruitment,training, and job redesign solutions. e2i is a tripartite initiative of theNational Trades Union Congress set up to support nation-wide manpower andskills upgrading initiatives.

By applying for this role, you consent to GMPTechnologies (S) Pte Ltd’s PDPA and e2i’s PDPA.

Job Description:

• In charge of performing quality assurance functions with regard to the product, process and maintain quality management system while ensuring compliance with all customers’ requirements
• Responsible for reviewing and revising quality procedures and quality control instructions
• Liaise with customers / vendors / suppliers on non-conformance activities, perform root cause analysis and determine effective corrective actions to reduce or eliminate the cost of poor quality
• In charge of performing internal audits to evaluate quality system, products, and processes
• In charge of performing vendors’ and on-site audits as required
• Drive down monthly Cost of Poor Quality/ scrap

Requirements:

• Degree in Mechanical / Aeronautical Engineering / other relevant disciplines
• Minimum 2 years of experience in Quality Management System and NADCAP

To submit your application, please apply online to apply@rn-care.com or call +(65) 6513 5697 for private and confidential discussion.

Your interest will be treated with the strictest of confidence. We regret that only shortlisted candidates will be notified or contacted.

RN Care Pte. Ltd
EA License No: 17C8900

Job Description:

• In charge of performing quality assurance functions with regard to the product, process and maintain quality management system while ensuring compliance with all customers’ requirements
• Responsible for reviewing and revising quality procedures and quality control instructions
• Liaise with customers / vendors / suppliers on non-conformance activities, perform root cause analysis and determine effective corrective actions to reduce or eliminate the cost of poor quality
• In charge of performing internal audits to evaluate quality system, products, and processes
• In charge of performing vendors’ and on-site audits as required
• Drive down monthly Cost of Poor Quality/ scrap

Requirements:

• Degree in Mechanical / Aeronautical Engineering / other relevant disciplines
• Minimum 5 years of experience in QMS, AS9100, NADCAP

To submit your application, please apply online to apply@rn-care.com or call +(65) 6513 5697 for private and confidential discussion.

Your interest will be treated with the strictest of confidence. We regret that only shortlisted candidates will be notified or contacted.

RN Care Pte. Ltd

EA License No: 17C8900