
Senior Quality Manager Quality Assurance
- Zürich
- Unbefristet
- Vollzeit
- Serve as the Quality Management Representative for the Zurich site and manufacturer of the Centrimag product line.
- Ensure compliance with global quality system regulations (USA, EU, Korea, Brazil, Australia, Canada, Ukraine, Switzerland).
- Lead site readiness for inspections and audits, and represent the facility during regulatory and internal audits.
- Lead and mentor a diverse team across operations quality, regulatory compliance, supplier quality, and new product development.
- Foster a culture of inclusion, collaboration, and continuous learning.
- Identify and manage resource needs to support operational excellence and future growth.
- Oversee quality system processes including document control, CAPA, risk management, supplier evaluations, and complaint handling.
- Support centralized functions like Regulatory Affairs and vigilance reporting with timely and accurate data.
- Drive improvements through data analysis and quality management reviews.
- Own final decisions on product quality and release, ensuring compliance and customer protection.
- Manage non-conformance evaluations and ensure timely resolution aligned with patient safety.
- Plan and manage the Quality department budget in alignment with business objectives.
- Collaborate with Finance, Site Director, and divisional leadership to ensure responsible and strategic resource allocation.
- Partner with Operations, R&D, and external stakeholders to resolve quality issues and support product development.
- Contribute to Zurich site strategy and support the integration of new manufacturing processes.
- A Master’s degree in Science, Engineering, or a related technical field, with 10+ years of experience in the medical device industry.
- At least 5 years of leadership experience in a quality systems environment, ideally within medical devices.
- Strong understanding of ISO standards and global regulatory frameworks (e.g., US, EU) related to medical devices.
- Proven ability to lead and inspire teams, with a focus on coaching, development, and inclusive leadership.
- Comfortable using business and technical software tools; open to learning new systems.
- Strong analytical and decision-making skills, with a collaborative and solution-oriented mindset.
- Excellent communication skills in English, with German proficiency considered an asset for engaging a broad range of stakeholders.
- Able to work independently and collaboratively across global teams, including remote sites.
- Highly organized, with strong time management and prioritization abilities.
- Skilled in building relationships and navigating complex environments with empathy and professionalism.
- Committed to ethical standards and delivering high-quality outcomes.
- Career development with an international company where you can grow
- A workplace in a fortune 500 company and the world’s leading manufacturer of medical devices
- A challenging position in a crisis independent industry
- To become part of a dynamic, highly educated, highly skilled, and motivated team
- Multi-national environment, where we foster the development of our talents within the enterprise
- Competitive compensations and benefits
- A workplace in the heart of Zurich
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