Job Responsibilities:

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.

3. CAPA and Non-Conformance Management

· 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.

Requirements

Education

· Bachelor’s degree in engineering, Quality Management, Manufacturing Engineering, Industrial Engineering, Science, or a related discipline.

Experience

· Minimum 3–5 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.

QMS Compliance Engineer