We are looking for a QA Lead who has strong expertise in establishing and maintaining Quality Management Systems compliant with ISO 13485, 21 CFR Part 820 (FDA QSR/QMSR), EU MDR 2017/745, and ISO 14971. Experienced in document control, change management, risk management, CAPA, complaint handling, and supplier quality management within regulated environments. Proven ability to support regulatory submissions including 510(k), PMA, De Novo, and CE Mark, and act as a key quality representatives during audits and inspections. Skilled in validation oversight, root cause analysis, and integrating risk-based approaches across product lifecycle processes. Committed to driving compliance, operational excellence, and a culture of continuous quality improvement.
Key Responsibilities
Quality Management System (QMS)
- Own and continuously improve the QMS in accordance with ISO 13485, 21 CFR Part 820 (US FDA QSR / QMSR), and EU MDR 2017/745.
- Leverage pharma-background experience (ICH guidelines, GMP) to strengthen procedural rigor and documentation standards.
- Support internal and supplier audits.
Document Control & Change Management
- Oversee document control processes including SOPs, work instructions, validation protocols, and design history files (DHF).
- Manage change control processes to ensure design and process changes are evaluated, documented, and approved per regulatory requirements.
Risk Management
- Lead risk management activities in accordance with ISO 14971, including hazard analysis, FMEA, and benefit-risk assessments.
- Integrate risk-based thinking into product development, manufacturing, and post- market activities.
Nonconformance, CAPA & Complaint Handling
- Oversee nonconformance investigations, root cause analysis, and CAPA programs.
- Manage the complaint handling process and MDR/vigilance reporting obligations in the US, EU, and other applicable markets.
Validation & Testing Oversight
- Collaborate with R&D and manufacturing on design verification and validation (V&V) activities.
Supplier Quality
- Maintain the approved supplier list (ASL) and conduct supplier qualification, audits, and performance monitoring.
Regulatory Support
- Support 510(k), De Novo, PMA, and CE Mark submissions from a quality perspective.
- Act as quality SME during FDA inspections and notified body audits.
Team Mentor
- Foster a culture of quality and continuous improvement across the organization.
Skills Required
- 5+ years of quality assurance experience, with at least 3 years in medical devices.
- Internal Auditor certification in ISO 13485:2016.
- Prior experience in pharmaceutical or biotech quality is required.
- Demonstrated expertise with ISO 13485, 21 CFR Part 820/QMSR, EU MDR, and ISO 14971.
- Hands-on experience leading regulatory inspections and notified body audits.
- Strong knowledge of CAPA methodologies, root cause analysis tools (e.g., Fishbone, 5-Why, FMEA).
- Experience with eQMS platforms
Education Qualification:
- Bachelor's degree in Life Sciences, Engineering, Pharmacy, or a related field (Master's preferred).
