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).