Quality Assurance Project Manager - Medical Devices (m/f/d)
nemensis agQuality Assurance Project Manager – Medical Devices (m/f/d)
Shape the Future of Medical Device Quality One Project at a Time
? Duration: approx. 12 months | extension possible
? Location: Basel
? Employment type: Temporary
About Our Client
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.
Your Responsibilities
- 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
Your Profile
- 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
Why nemensis?
- nemensis AG is your specialized recruitment partner in the Life Sciences sector, headquartered in Basel
- Comprehensive, personalized support throughout the entire application process by our experienced consultants
- Access to an extensive client network and exciting opportunities across Northwestern Switzerland
- Fast and straightforward onboarding through individual guidance and dedicated consulting
At nemensis ag, we have connected thousands of candidates with their next career step opening doors to growth, change, and new possibilities. What can we do for you and your career today? We look forward to hearing from you!
? Phill Rogers, Consultant, Write an email
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