Freelance QA Specialist Medical Devices

Freelance Interim Quality Manager – MedTech (Canton de Vaud)

Location : 80% On-site in Canton de Vaud, Switzerland

Contract Duration : 8-month contract (potential for renewal)

Start Date : Mid-May 2025

Interview Process : 1-stage Teams interview with an offer on the same day

Type of contract: FREELANCE/INTERIM/SELF-EMPLOYED ONLY

Responsibilities :

• Lead the Quality department to ensure compliance with medical device regulations, including ISO 13485, EU MDR, and GMP.
• Oversee the Quality Assurance and Document Control teams, ensuring effective operations.
• Drive CAPA, non-conformance investigations, and complaint handling, implementing corrective actions where necessary.
• Manage the Quality Management System (QMS), training records, and internal/external audits.
• Prepare for and manage regulatory inspections, ensuring successful completion.
• Act as the Management Representative for ISO 13485 compliance.
• Lead continuous improvement initiatives and ensure quality performance metrics are met.
• Support change controls, process validations, and risk management activities.

Who We’re Looking For :

• 5+ years of Quality Assurance experience in the medical device sector.
• Strong knowledge of ISO 13485, EU MDR, GMP, and CAPA processes.
• Proven experience leading quality teams and collaborating cross-functionally with regulatory, manufacturing, and engineering teams.
• Hands-on experience with document control, audits, and QMS maintenance.
• Strong problem-solving abilities, leadership skills, and stakeholder management experience.
• Fluent in English (knowledge of French or German is a plus).
• Must be available as a freelancer for the contract duration.

Why This Role?

This is a fantastic opportunity for an experienced freelance Interim Quality Manager to step into a leadership role at a growing MedTech company in the Canton de Vaud, Switzerland. You will play a critical role in ensuring compliance and driving continuous improvement within the organization.

If you\’re interested in discussing this opportunity further, please send your CV to .

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