Design Quality Assurance Manager

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.

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.

• 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.