Head of Quality

Haybury; Bern; Vor Ort; CHF 180.000 - 240.000; Vollzeit

Zusammenfassung

Haybury is seeking a Head of Quality in the MedTech space to lead a 40+ person Quality organization, shaping strategy and ensuring safe, compliant, and patient-focused medical devices. Reporting to the COO, this role spans across Design, Operations and Supplier Quality, with responsibility for post-market surveillance and regulatory readiness.

The ideal candidate will drive a pragmatic, risk-based operating model, balance strategic thinking with hands-on leadership, and partner with R&D,

Qualifikationen

• Significant Quality leadership experience within the MedTech industry.

Aufgaben

• Define and execute the global Quality strategy, governance framework, and objectives.
• Lead Quality across Design Quality, Operations Quality, Supplier Quality, Complaint Management & Post-Market Surveillance, and Quality Systems Management.
• Drive the transformation and simplification of quality systems, processes and ways of working while maintaining robust regulatory compliance.
• Embed a customer- and patient-focused approach to quality across the entire product lifecycle.
• Partner closely with R&D, Product Development, Operations, Supply Chain, Commercial and Customer Service functions.
• Lead and develop an established, multi-layered team through organisational growth and change.
• Represent Quality internally with senior leadership and externally with regulatory authorities, notified bodies, auditors and key partners.
• Support major product launches, innovation programmes and international expansion activities.

Kenntnisse

Quality leadership

MedTech exposure

Regulatory compliance

ISO 13485 knowledge

Jobbeschreibung

Head of Quality – MedTech

A rare opportunity has arisen for an accomplished Quality leader to join a growing and innovative medical technology organisation dedicated to improving the lives of people living with chronic conditions through connected medical devices and digital health solutions.

Reporting directly to the Chief Operating Officer and operating as a key member of the senior leadership team, the Head of Quality will lead a business-critical Quality organisation of approximately 40+ professionals across multiple specialist functions. This role offers significant visibility and influence, with responsibility for shaping Quality strategy, driving organisational transformation, and ensuring the organisation continues to deliver safe, compliant, reliable, and customer-focused products.

This is more than a traditional Quality leadership role. The successful candidate will play a pivotal role in evolving the Quality function towards a pragmatic, risk-based and scalable operating model that supports growth while maintaining the highest standards of compliance and patient safety.

Key Responsibilities

• Define and execute the global Quality strategy, governance framework, and objectives.


• Lead Quality across Design Quality, Operations Quality, Supplier Quality, Complaint Management & Post-Market Surveillance, and Quality Systems Management.


• Drive the transformation and simplification of quality systems, processes and ways of working while maintaining robust regulatory compliance.


• Embed a customer- and patient-focused approach to quality across the entire product lifecycle.


• Partner closely with R&D, Product Development, Operations, Supply Chain, Commercial and Customer Service functions.


• Lead and develop an established, multi-layered team through organisational growth and change.


• Represent Quality internally with senior leadership and externally with regulatory authorities, notified bodies, auditors and key partners.


• Support major product launches, innovation programmes and international expansion activities.

Essential Experience

We are seeking an experienced Quality executive with:

• Significant Quality leadership experience within the MedTech industry.


• A proven track record leading sizeable Quality organisations and developing senior leaders.


• Broad understanding of Design Quality, Operations Quality, Supplier Quality, Post-Market Surveillance and Quality Systems.


• Strong knowledge of ISO 13485, European medical device regulations and regulatory inspection readiness.


• Experience driving quality transformation, process improvement and organisational change.


• Exposure to FDA-regulated environments and/or supporting US market activities.


• The ability to balance strategic thinking with a practical, hands-on leadership approach

Why Apply?

This is an opportunity to shape the future of Quality within a growing, technology-driven medical device organisation at an exciting stage of its journey. You will have the platform to influence business strategy, lead meaningful change, develop a high-performing team and help deliver products that make a genuine difference to patients' lives.