Design Quality Assurance Manager

Thoratec Switzerland GmbH; Zürich; Vor Ort; CHF 120.000 - 160.000; Vollzeit

Benefits dieser Stelle

Zurich workplace

Flexibility

Growth opportunities

Zusammenfassung

Thoratec Switzerland GmbH in Zürich is seeking a Design Quality Assurance Manager to ensure design controls, risk management, and product quality across the development lifecycle for life-saving medical devices.

You will lead Design Quality Engineers, partner with R&D, Regulatory, Manufacturing and Clinical teams, and drive continuous improvement in a global, regulated environment based in Zurich. This role offers a dynamic mix of leadership, hands-on quality work, and strategic input.

Qualifikationen

• Master’s degree in science or engineering and relevant healthcare experience.
• Minimum five years in medical device industry.
• At least two years in people management.
• Deep knowledge of ISO 13485 and regulatory requirements (21 CFR 820, EU MDR).
• Experience in large, global, regulated organizations with leadership.
• Strong stakeholder management and communication skills.
• Design for Six Sigma or Quality by Design experience is a plus.

Aufgaben

• Lead quality assurance activities across the product development lifecycle.
• Act as Quality representative on cross-functional teams; ensure Design Control compliance.
• Drive quality planning for new product development; oversee design changes.
• Lead, coach, and develop Design Quality Engineers and QA staff.
• Set objectives, manage resources, and prioritize projects.
• Promote a culture of quality, compliance, and continuous improvement.

Kenntnisse

Leadership experience

Stakeholder management

Regulatory knowledge

People management

Quality systems

Ausbildung

Master’s degree in science/engineering

Jobbeschreibung

Design Quality Assurance Manager

Thoratec Switzerland GmbH

Design Quality Assurance Manager – Drive Impact in Life-Saving Innovation

Location: Zurich, Switzerland

At Abbott’s Thoratec Switzerland GmbH, we develop technology that saves lives. As part of Abbott’s global medical device division (115,000+ employees worldwide), we are leaders in implantable and extracorporeal blood pump systems using advanced magnetic levitation technology.

From our Zurich site, a diverse team of ~130 colleagues collaborates across development, quality, and production to deliver the CentriMag System and HeartMate 3—supporting patients with advanced heart failure around the world.

Why this role matters

Are you passionate about advancing innovative healthcare solutions that make a meaningful impact on patients' lives? As a Design Quality Assurance Manager, you will play a key role in ensuring quality, compliance, and product excellence throughout the development lifecycle. Working at the intersection of innovation and quality, you will partner closely with cross-functional teams, including R&D, Regulatory Affairs, Manufacturing, Clinical, and Project Management, to support the delivery of safe, effective, and compliant products.

In this influential role, you will help shape and strengthen design control processes, risk management practices, and product development quality systems while fostering a culture of collaboration and continuous improvement. As a trusted quality partner, you will provide strategic guidance across product development activities, helping teams navigate regulatory requirements and quality expectations while enabling innovation and driving positive outcomes for both the business and the patients we serve.

What You'll Do

• Lead Design Quality Assurance activities throughout the product development lifecycle.
• Serve as the Quality representative on cross-functional product development teams. Ensure implementation and compliance with Design Control requirements.
• Drive quality planning activities for new product development projects. Provide quality oversight for design changes and product enhancements.
• Lead, coach, and develop Design Quality Engineers and other quality professionals.
• Establish team objectives, performance expectations, and development plans. Manage resource planning and project prioritization.
• Promote a culture of quality, compliance, and continuous improvement.

What You Bring

• Master’s degree in science, engineering or another technical field is required.
• At least five years of related experience in a medical device industry.
• At least 2 years experience of people management.
• In-depth knowledge of ISO 13485, international medical device regulatory requirements (21 CFR part 820, EU MDD/MDR), MDSAP and other regional requirements as applicable
• Proven experience working in a large, global, regulated organization in a leadership position.
• Strong stakeholder management and communication skills.
• Experience with Design for Six Sigma or Quality by Design methods will be considered a strong plus.

What we offer

• A purpose-driven role contributing to life-saving technologies
• A collaborative and inclusive culture where different perspectives are valued
• Opportunities for growth and specialization (including becoming a costing SME)
• Flexibility and autonomy in how you manage your work
• A modern workplace in the heart of Zurich

• Work location 8005 Zürich (ZH)
• Workload 100%
• Employment start By agreement
• Employment duration Permanent

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