Quality Assurance Project Manager – Medical Devices; m​/f​/d

Quality Assurance Project Manager – Medical Devices (m/f/d)

Shape the Future of Medical Device Quality One Project at a Time

For our client, a globally operating, research-driven company in the pharmaceutical and life sciences industry, we are looking for an experienced Quality Assurance Project Manager – Medical Devices (m/f/d). With a strong presence in Basel and a broad international footprint, our client is recognized for its innovation in drug delivery systems and medical device development, setting standards in quality and compliance across the industry.

• Represent QA in global cross‑functional device development project teams, quality board meetings, and development gate reviews
• Provide quality oversight and scientific guidance across assigned medical device development projects, ensuring alignment with regulatory and internal requirements
• Develop and contribute to project strategies, including risk assessments and contingency planning, to secure timely delivery of quality milestones
• Act as QA approver for technical documentation, deviation records, and OOX entries (e.g. Trackwise system)
• Support and coordinate Notified Body inspections, including preparation and hosting activities
• Contribute to the authoring and maintenance of QMS documentation (SOPs, Work Packages, Forms, Attachments)
• Conduct and support impact assessments for design changes, manufacturing modifications, and evolving regulatory standards
• Manage project trackers and prepare relevant materials for governance and management forums
• Provide input to QA agreements and contracts with third‑party partners and approve project-specific amendments

• Academic background:
  Bachelor's degree with 10+ years of experience, or Master's degree with 5+ years of experience in pharmaceutical quality or operations
• Solid expertise in quality standards and regulatory requirements applicable to medical device development and manufacturing
• Demonstrated experience with Notified Body Inspections and design control processes
• Proven track record in leading interdisciplinary, matrix-based teams in a technical or scientific R&D environment
• Strong strategic thinking combined with hands‑on quality implementation skills
• Proficiency in MS Office and document management systems; openness to learning new digital tools and processes
• Fluent English (written and spoken) required; additional local language skills are a plus