Senior Quality Manager Quality Assurance

Are you a strategic leader passionate about quality, innovation, and making a difference in healthcare? Join our Zurich team as Senior Manager Quality Assurance, where you ll lead with purpose, foster collaboration, and shape the future of our quality systems in a dynamic and inclusive environment.

Position Overview

As the Senior Quality Manager Quality Assurance for our Zurich site, you ll be the key point of contact for all quality-related matters, including interactions with external regulators and Notified Bodies. You ll lead the development and execution of our site s Quality strategy, ensuring alignment with global standards and business goals, while championing continuous improvement and operational excellence.

This role offers a unique opportunity to influence site-wide strategy, guide cross-functional teams, and support the expansion of manufacturing capabilities, including clean room processes. You ll work closely with senior leadership and empower a talented team to deliver high-quality, safe, and compliant products that improve lives.

Key Responsibilities

Compliance & Regulatory Leadership

• 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.

Team Leadership & Development

• 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.

Quality Systems & Process Excellence

• 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.

Product Acceptance & Customer Safety

• 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.

Strategic Planning & Budget Management

• 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.

Cross-Functional Collaboration

• 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.

Qualifications What Will Help You Thrive in This Role

• 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.

Working at Abbott

At Abbott, you can do work that matters and help people to live a healthier and fuller life, grow your career, and learn, be your true self. You will have access to:

• 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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