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Senior Quality Assurance Manager – Medical Devices & Combination Products (M/W/D)
Responsibilities:
Provide quality leadership and strategic guidance for global medical device and combination product development projects within a matrix organization.
Act as QA representative for Global Device and Packaging Development (GDPD) project teams and contribute to project governance meetings and development milestones.
Ensure quality oversight throughout the device development lifecycle, including risk assessments, quality strategies, and compliance activities.
Support cross-functional teams in resolving quality-related topics and ensure alignment with internal QA strategies and external regulatory requirements.
Review and approve technical documentation, quality records, deviations, and change-related assessments within medical device development projects.
Support the preparation and hosting of Notified Body inspections and regulatory audits.
Contribute to the development and maintenance of Quality Management System (QMS) documentation, including SOPs, work instructions, and quality agreements.
Support the assessment of new medical device regulations and standards and coordinate related implementation activities.
Lead and contribute to global quality initiatives and continuous improvement projects.
Collaborate closely with internal stakeholders including Device Development, R&D, Regulatory Affairs, Manufacturing, and external partners.
Qualifications:
Bachelor’s or Master’s degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a related scientific discipline.
Minimum 5+ years of experience in Quality Assurance, preferably within medical devices, combination products, or drug delivery systems.
Strong knowledge of medical device quality standards and regulations, including ISO 13485, ISO 14971, EU MDR, and FDA device requirements.
Proven experience in medical device development, design controls, risk management, and technical documentation.
Experience supporting or participating in Notified Body inspections and regulatory audits.
Demonstrated ability to lead cross-functional teams and work effectively in a global matrix organization.
Experience with Quality Management Systems (QMS), deviation management, CAPA, change control, and electronic quality systems (e.g., TrackWise).
Strong communication and stakeholder management skills.
Fluent English required (written and spoken); additional local language skills are a plus.
Framework Data:
Start: ASAP
Duration: 11 months
Workload: Full-time (5 days per week)
Location: Basel
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