Design Quality Assurance Manager

Switzerland - Zurichmid

OtherQuality Assurance Manager

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Overview

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.

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OtherQuality Assurance Manager

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.

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.

Responsibilities

~1 min read

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

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.