European QA Leader - Surgical Devices

Synova Partners; Amsterdam; On-site; EUR 90,000 - 140,000; Full time

Job summary

Synova Partners is assisting a high growth medical device company as they establish their European Headquarters in the Netherlands. They seek a Quality Assurance Manager, Europe, to build and lead the European QA framework and ensure compliance with EU MDR and ISO 13485.

The role initially is a hands-on contributor position with potential to grow into a regional QA leadership role, partnering with Regulatory Affairs, RA/PRRC, and manufacturing quality teams across Europe.

Qualifications

• Bachelor-level or higher in life sciences or related field.
• Minimum 8 years in QA/Quality Compliance in medical devices.
• Strong knowledge of EU MDR 2017/745, ISO 13485:2016, ISO 14971:2019.
• Experience leading Notified Body audits and regulatory inspections.
• Experience establishing or improving a QMS across Europe.
• English proficiency, written and spoken.

Responsibilities

• Establish and maintain European QMS per EU MDR and ISO 13485.
• Serve as Quality representative for Europe; guide management.
• Support importer/Authorized Representative quality processes.
• Manage CAPA, complaints, nonconformities, root cause investigations.
• Coordinate post-market surveillance and vigilance with RA/PRRC.
• Oversee post-market quality activities and SIRs/FSNs.
• Coordinate Notified Body audits and regulatory inspections.
• Develop QA oversight of distributors and third parties.
• Promote quality compliance culture; train staff.
• Grow European QA team as business expands.

Skills

Quality management

EU MDR 2017/745

CAPA

Notified Body audits

Regulatory liaison

English proficiency

Education

Bachelor's degree in life sciences

Job description

Synova Partners is assisting a high growth medical device company as they establish their European Headquarters in the Netherlands. They seek a Quality Assurance Manager, Europe, to build and lead the European QA framework and ensure compliance with EU MDR and ISO 13485.

The role initially is a hands-on contributor position with potential to grow into a regional QA leadership role, partnering with Regulatory Affairs, RA/PRRC, and manufacturing quality teams across Europe.