Design Quality Assurance Manager — Abbott

Full 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. If this sounds like you, we would love to hear from you.

Apply via our career site: Abbott Laboratories Careers

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