Lead Quality Assurance Specialist

Lead Quality

Work Flexibility: Hybrid

What will you do

• Manage Non-Conformity (NC) and Corrective and Preventive Action (CAPA) processes, support investigations across functions.
• Review, prepare, and update QMS documentation (procedures, work instructions, forms, policies) via Change Control processes.
• Execute Change Control activities in Windchill (onePLM) and manage corporate document changes through CIDT dispositions.
• Develop and execute the Annual Supplier Audit Plan; perform supplier audits and manage supplier-related non-conformities.
• Maintain Approved Supplier List (ASL) and support supplier performance reviews. Support with Management Review Meetings and coordinate Internal Quality Agreements (IQA) with divisions.
• Review and approve RAQA assessments for Indirect Channel (IC) partners/ distributors.
• Review document management for collateral materials and support validation activities as per QMS processes. Conduct internal audits per the audit program and coordinate Quality Review Board (QRB) meetings.
• Support warehouse quality team with label Master updates and product inspections.
• Manage electronic QMS systems such as Track Wise, training systems, and documentation platforms. Plan and coordinate training activities with functional heads to enhance the QMS; maintain and update the annual Training Plan.
• Perform additional duties as assigned by the Manager.

Technical Expertise

• Strong understanding of ISO 13485, Good Distribution Practices (GDP), and regulatory requirements for medical devices.
• Knowledge of quality improvement methodologies and compliance frameworks.

What you need

• Experience: minimum 6 and maximum 8 years in Quality function within Medical Device or Pharmaceutical industry.
• Education: Master’s degree in biomedical engineering, Biotech Engineering, Life Sciences, or Pharmacy.
• Certifications: ISO 13485:2016 Lead Auditor certification.
• Proven experience in QMS development, implementation, and maintenance aligned with local regulations.
• Expertise in audits (supplier, internal, corporate) and compliance risk management.
• Ability to work independently with a strong sense of urgency and follow-up.
• Willingness to travel up to 20% (warehouses and suppliers/distributors).

Travel Percentage: 20%

Experience Level

Senior Level