Senior Quality Assurance Manager - Europe

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

Manager of Quality Assurance - EU (Surgical Devices)

Our client are a high growth medical device company with an established portfolio of surgical products and a growing international presence.

As part of our continued expansion in Europe, they are establishing our European Headquarters in the Netherlands and strengthening our local Quality and Regulatory capabilities.

They are looking for an experienced Quality Assurance Manager, Europe to establish and lead our European quality activities and support the continued growth of the business across the region.

Depending on the candidate's experience and seniority, the position may be considered at Senior QA Manager level.

The Role

This is an exciting opportunity to join an early stage of our European expansion.

Working closely with the General Manager, Europe, Head of International Quality, Regulatory Affairs/PRRC and our manufacturing quality teams, the successful candidate will be responsible for establishing and maintaining an effective European Quality Management System and ensuring ongoing compliance with applicable European medical device requirements.

The role will initially operate as an individual contributor, with the opportunity to build and develop a European QA team as the business grows.

Key Responsibilities:

• Establish, implement and maintain the European Quality Management System in accordance with EU MDR and ISO 13485 requirements.
• Serve as the key Quality representative for the European organisation and provide practical quality guidance to local management and business teams.
• Support the establishment of the Company's European importer and Authorised Representative quality processes and responsibilities.
• Manage key quality processes including complaints, nonconformities, CAPA, root cause investigation and post-market quality activities.
• Work closely with Regulatory Affairs/PRRC on post-market surveillance, vigilance reporting and field safety corrective actions, where required.
• Manage European post-market quality and vigilance activities, including applicable Serious Incident Reports (SIRs), Field Safety Corrective Actions (FSCAs), Field Safety Notices (FSNs) and EUDAMED requirements, in collaboration with RA/PRRC.
• Coordinate and support Notified Body audits, competent authority inspections and internal/external quality audits.
• Establish appropriate quality oversight of European distributors, importers and other relevant third parties.
• Partner with manufacturing and Quality teams to ensure effective communication, investigation and resolution of European quality matters.
• Provide quality training and promote a strong quality and compliance culture across the European organisation.
• Support the development of the European QA organisation and recruit additional QA resources as the business expands.

Candidate Profile

We are looking for a hands-on and pragmatic Quality professional who is comfortable operating independently in a growing international organisation.

• Bachelor's degree or above in life sciences, biomedical engineering, quality management or a related discipline.
• Minimum 8 years of Quality Assurance / Quality Compliance experience within the medical device industry, with significant exposure to the European market.
• Strong working knowledge of EU MDR 2017/745, ISO 13485:2016 and ISO 14971:2019.
• Hands-on experience with key quality processes including CAPA, complaints, nonconformity management and root cause investigation.
• Experience supporting or leading Notified Body audits and regulatory inspections.
• Good understanding of post-market surveillance and European medical device vigilance requirements.
• Experience developing, implementing or significantly improving a Quality Management System.
• Strong stakeholder management and communication skills, with the ability to work effectively across different countries and cultures.
• Professional working proficiency in English, both written and spoken.

Advantageous Experience:

The following would be beneficial but are not essential:

• Experience with Class IIb/III medical devices or surgical products.
• Experience establishing a QA function or QMS within a start-up, new entity or high-growth organisation.
• Experience with European importer/distributor quality management.
• Experience working directly with European competent authorities.
• Familiarity with MDSAP.
• Working proficiency in Dutch.
• Experience working with Asian or China-based manufacturing organisations.

What We Are Looking For:

The successful candidate will be:

• Hands-on – comfortable developing processes as well as implementing them.
• Independent – able to establish priorities and operate effectively with limited local infrastructure during the initial stage.
• Pragmatic – able to translate regulatory requirements into practical, effective and sustainable quality processes that support a growing organisation.
• Collaborative – comfortable working across Quality, Regulatory, Commercial and Operations functions.
• Growth-oriented – interested in building a European QA capability rather than simply maintaining an established system.

Why Join:

This role provides an opportunity to play a key part in establishing the European organisation.

The successful candidate will have significant ownership of the European quality framework from an early stage and, as the business grows, the opportunity to build a local QA team and take on broader European Quality leadership responsibilities.