Design Quality Assurance Manager

Thornton Tomasetti; Zürich; Vor Ort; CHF 140.000 - 190.000; Vollzeit

Benefits dieser Stelle

Purpose-driven role

Collaborative culture

Growth opportunities

Flexibility

Zurich workplace

Zusammenfassung

Abbott’s Thoratec Switzerland GmbH in Zurich develops life-saving medical devices and supports patients worldwide. The Design Quality Assurance Manager will lead quality activities across the product development lifecycle, ensuring design controls and risk management while partnering with R&D, Regulatory Affairs and Manufacturing.

From the Zurich site, you’ll guide a team of quality engineers, drive continuous improvement, and shape quality systems to enable safe and effective devices such as

Qualifikationen

• Master’s degree in science, engineering or another technical field.
• 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 and regulatory requirements (21 CFR 820, EU MDR).
• Experience in a large global regulated organization in a leadership position.

Aufgaben

• 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.

Kenntnisse

Stakeholder management

Communication skills

Design for Six Sigma

Quality by Design

Ausbildung

Master’s degree in science, engineering or another technical field

Jobbeschreibung

JOB DESCRIPTION: 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

Join us

We are looking for curious, motivated individuals who enjoy solving problems, working together, and making an impact.

We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings.

The base pay for this position is N/A In specific locations, the pay range may vary from the range posted.

JOB FAMILY: Operations Quality DIVISION: HF Heart Failure LOCATION: Switzerland : Technoparkstrass 1 CH 8005 ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Not specified MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Not Applicable

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next‑generation diagnostics, life‑changing devices, science‑based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well‑being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.