Design Quality Assurance Manager – Life-Saving Med Devices

Abbott; Zürich; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Benefits dieser Stelle

Purpose-driven role

Collaborative culture

Growth opportunities (including SME)

Autonomy at work

Zurich-based workplace

Zusammenfassung

Abbott’s Thoratec Switzerland GmbH in Zurich develops life-saving medical devices and seeks a Design Quality Assurance Manager to ensure quality and regulatory compliance across the development lifecycle. You will partner with R&D, Regulatory Affairs, Manufacturing, Clinical and Project Management to deliver safe, effective products and strengthen design controls.

You will lead QA activities, shape risk management processes, and enable continuous improvement while guiding a team of quality

Qualifikationen

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

Aufgaben

• Lead Design Quality Assurance activities throughout the product development lifecycle.
• Serve as the Quality representative on cross-functional product development teams; ensure Design Control compliance.
• Drive quality planning for new product development; 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

Leadership

Stakeholder management

Communication skills

Quality assurance

Quality by Design

Ausbildung

Master’s degree in science/engineering or technical field

Jobbeschreibung

Abbott’s Thoratec Switzerland GmbH in Zurich develops life-saving medical devices and seeks a Design Quality Assurance Manager to ensure quality and regulatory compliance across the development lifecycle. You will partner with R&D, Regulatory Affairs, Manufacturing, Clinical and Project Management to deliver safe, effective products and strengthen design controls.

You will lead QA activities, shape risk management processes, and enable continuous improvement while guiding a team of quality