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: 

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