Responsable Assurance Qualité Conception

Jobup; Zürich; Vor Ort; CHF 150.000 - 190.000; Vollzeit

Benefits dieser Stelle

Purpose-driven role

Collaborative culture

Growth opportunities

Flexibility and autonomy

Zurich workplace

Zusammenfassung

Abbott’s Thoratec Switzerland GmbH in Zurich develops life-saving medical devices and seeks a Design Quality Assurance Manager to uphold quality, compliance, and product excellence across development.

You will lead QA activities, guide engineers, partner with R&D, regulatory, and manufacturing, and foster continuous improvement in a fast-paced, global organization.

Qualifikationen

• Master’s degree in science, engineering, or related technical field.
• 5+ years in the medical device industry.
• 2+ years in people management.
• Knowledge of ISO 13485 and regulatory requirements (21 CFR 820, EU MDR/MDD) and MDSAP.
• Experience in a large, global, regulated organization in a leadership role.
• Strong stakeholder management and communication skills.
• Design for Six Sigma or Quality by Design experience is a plus.

Aufgaben

• Lead design quality assurance activities throughout product development.
• Serve 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 team objectives, performance expectations, and development plans.
• Promote culture of quality, compliance, and continuous improvement.

Kenntnisse

Leadership

Stakeholder management

Quality management

Regulatory knowledge

Quality by Design

Communication skills

Ausbildung

Master’s degree in science or engineering

Jobbeschreibung

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.