Job Title: Contract Quality Assurance Manager
Maternity Leave Coverage – 12-Month Contract
Location: Basel, Switzerland
Reports to: Head of Quality Assurance
About the Role
We are looking for a dedicated Contract Quality Assurance Manager to join our Basel-based team for a 12-month maternity leave cover. You will lead quality assurance efforts for our endoluminal soft robotic systems—innovative medical devices used in Interventional Neuro Radiology to treat Ischemic and Hemorrhagic strokes.
This is a critical role focused on ensuring the quality, safety, and regulatory compliance of our products. You’ll work closely with cross-functional teams across R&D, Regulatory Affairs, and Manufacturing to maintain and enhance our quality systems.
Key Responsibilities
Quality Management & Compliance
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Maintain and improve our Quality Management System (QMS) in line with ISO 13485, FDA 21 CFR Part 820, and other regulations.
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Monitor compliance with GxP standards and support regulatory submissions.
Supplier & Risk Management
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Qualify and monitor suppliers; conduct supplier audits and manage corrective actions.
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Lead risk management activities following ISO 14971 and implement mitigation strategies.
Audits & Inspections
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Plan and execute internal audits; prepare for and support external inspections (e.g., FDA, notified bodies).
CAPA & Documentation
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Oversee CAPA investigations and manage deviation reports.
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Ensure product batches meet specifications before release.
Cross-functional Collaboration
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Coordinate with R&D, Regulatory, and Manufacturing teams to support the full product lifecycle.
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Deliver training on quality processes to maintain a strong compliance culture.
Qualifications
Education
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Bachelor’s degree in Engineering, Life Sciences, or a related field.
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A Master’s degree or certifications (CQE, CQA) are a plus.
Experience
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5+ years in Quality Assurance within the medical device industry.
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Experience with Class II or III devices, ideally in soft robotics or interventional radiology.
Skills
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Strong grasp of ISO 13485, ISO 14971, FDA QSR, and CE Marking.
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Proficient in problem-solving, documentation, and leading quality investigations.
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Excellent communication and ability to work cross-functionally.
Bonus Skills (Desirable but Not Required)
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Experience with robotic systems or neurovascular devices.
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Familiarity with medical device software validation.
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In-depth knowledge of risk management processes.
Why Join Us?
This is a great opportunity to contribute to life-saving technologies in a supportive and high-performing team. If you’re ready to take on a hands-on quality leadership role, we want to hear from you.
Apply Now: [email protected]