QMS Compliance Engineer
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Job Summary
1. Quality Management System (QMS)
Establish implement maintain and continuously improve the Quality Management System (QMS) in compliance with:
o ISO 13485
o ISO 14971
o FDA 21 CFR Part 820 / QMSR
o MDSAP requirements
o EU MDR requirements (where applicable)
o Customer-specific requirements
Ensure all quality procedures work instructions forms and records are maintained and controlled in accordance with document control requirements.
Monitor QMS effectiveness through KPI tracking quality performance metrics trend analysis and management reporting.
Coordinate and facilitate Management Review Meetings including preparation of inputs reports and follow-up actions.
2. Internal and External Audits
Develop and execute the annual internal audit program including planning scheduling conducting and reporting audit activities.
Prepare audit plans checklists reports and corrective action follow-up documentation.
Verify the implementation and effectiveness of corrective actions resulting from audit findings.
Act as the primary coordinator and host for:
o Customer audits
o Certification body audits
o Regulatory inspections
o Supplier audits
o MDSAP audits
Coordinate responses to audit observations findings and non-conformities.
Track audit findings and ensure timely closure of corrective and preventive actions.
Lead and facilitate Corrective and Preventive Action (CAPA) activities.
Conduct investigations using structured root cause analysis methodologies including:
o 5 Why Analysis
o Fishbone Diagram
o Fault Tree Analysis
o Pareto Analysis
o Failure Mode and Effects Analysis (FMEA)
Monitor CAPA progress effectiveness and closure.
Manage Non-Conformance Reports (NCRs) ensuring proper containment investigation disposition and resolution.
Support customer complaint investigations and associated CAPA activities.
4. Risk Management
Participate in risk management activities in accordance with ISO 14971.
Review maintain and update:
o Risk Management Files
o Risk Assessments
o Process FMEA
o Design FMEA
o Control Plans
Support cross-functional teams in identifying assessing mitigating and monitoring quality and regulatory risks.
5. Validation and Qualification
Support validation and qualification activities including:
o Installation Qualification (IQ)
o Operational Qualification (OQ)
o Performance Qualification (PQ)
Review and approve validation protocols reports and supporting documentation.
Ensure validation activities comply with applicable regulatory quality and customer requirements.
Support process revalidation and periodic validation reviews.
6. Change Control Management
Participate in Change Control Board (CCB) activities.
Review engineering process material and documentation changes.
Assess quality regulatory and business impacts associated with proposed changes.
Ensure all change controls are properly documented reviewed approved implemented and closed.
7. Document Control
Manage and maintain controlled documentation including:
o Standard Operating Procedures (SOPs)
o Work Instructions (WIs)
o Product and Technical Drawings
o Validation Documents (IQ/OQ/PQ)
o Quality Records (PQP QAS)
o Technical Files
Ensure document revisions are appropriately reviewed approved distributed and archived.
Monitor document retention archival processes and record management compliance.
8. Training and Compliance Awareness
Collaborate with Human Resources to develop and deliver QMS-related training programs.
Ensure employees receive appropriate training on:
o QMS requirements
o Regulatory requirements
o SOP revisions and updates
o Compliance expectations
o Other relevant quality topics
Maintain training records and evaluate training effectiveness in collaboration with Human Resources.
Promote a culture of quality compliance and continuous improvement throughout the organization.
9. Supplier Quality Management
Support supplier qualification and approval processes in collaboration with Supplier Quality Engineering (SQE).
Participate in supplier audits and supplier performance evaluations.
Review supplier quality agreements supplier corrective actions and improvement plans with SQE.
Monitor supplier quality performance metrics and trends.
10. Data Analysis and Continuous Improvement
Analyze quality performance data using statistical tools and quality methodologies.
Prepare and present periodic quality reports including:
o CAPA Metrics
o Audit Metrics
o Customer Complaint Trends
o NCR Trends
o Supplier Quality Performance
o QMS KPI Reports
Identify improvement opportunities and lead continuous improvement initiatives.
Support Lean Manufacturing Six Sigma and Operational Excellence programs.
11. Regulatory Compliance
Monitor updates and changes to applicable regulations standards and industry requirements.
Ensure organizational compliance with regulatory and customer requirements.
Support regulatory submissions and quality documentation requests.
Assist in preparing quality documentation for customer reviews audits and regulatory inspections.
12. General Responsibilities
Maintain confidentiality of quality regulatory and proprietary information.
Comply with company policies safety requirements and ethical standards.
Support business continuity operational excellence and quality improvement initiatives.
Perform other duties and responsibilities as assigned by management.
Education
Bachelors degree in engineering Quality Management Manufacturing Engineering Industrial Engineering Science or a related discipline.
Experience
Minimum 35 years of experience in Quality Assurance Quality Systems or Regulatory Compliance preferably within the medical device or regulated manufacturing industry.
Experience participating in customer certification body supplier and regulatory audits.
Hands-on experience managing CAPA NCR Change Control Validation and QMS activities.
Knowledge and Skills
Strong understanding of Quality Management Systems particularly ISO 13485.
Solid knowledge of medical device regulations and industry standards.
Excellent problem-solving analytical and decision-making skills utilizing structured root cause analysis techniques.
Proficient in documentation control quality reporting and quality management software systems.
Strong communication and interpersonal skills with the ability to collaborate effectively across departments and interact with external auditors and regulatory bodies.
Detail-oriented with the ability to identify compliance gaps and drive corrective actions.
Self-motivated proactive and committed to continuous improvement and regulatory compliance.
Required Skills:
Minimum 35 years of experience in project management and manufacturing operations or possession of a PMP certification/training qualification. Candidates with an engineering background and prior experience in the medical device industry will have an added advantage. Strong understanding of project management and operational processes with proven ability to manage day-to-day project activities milestone reviews project evaluations and progress reporting effectively. Demonstrated capability in problem identification root cause analysis issue tracking and resolution management with the ability to lead project teams in driving project progress and ensuring timely delivery of objectives. Excellent communication planning and coordination skills coupled with strong cost awareness and analytical thinking. Proficient in both English and Chinese reading comprehension with advanced competency in Microsoft Office applications.
Required Education:
Bachelors degree or higher in Mechanical Engineering Electronics Automation & Control Engineering Software Engineering Computer Science Bioengineering Clinical Medicine or other related disciplines.
