Medical Device Expert

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas.

As part of our ongoing growth and commitment to excellence, we are currently looking for a Medical Device Expert to join our international team in Barcelona. This is a unique opportunity to contribute to high-impact projects, working alongside top-tier professionals in an innovative and fast-paced environment.

Responsibilities include, but are not limited to:

• Participate in multiple projects in the medical devices sector, ensuring timely delivery and adherence to project budget and customer needs
• Support QA and RA activities at Medical Device Companies
• Ensure compliance with regulatory requirements and quality standards (e.g., FDA, ISO 13485, MDR, and IVDR)
• Establish, implement, review and update QMS procedures
• Implement CAPA process
• Participate in activities on Risk Management File
• Develop process validation protocols (IQ-OQ-PQ) and write summary reports
• Support regulatory activities for CE marking, MDR or IVDR certification (design and development activities, review of labelling materials, technical documentation preparation)
• Support Clinical Evaluation, Post Market Surveillance, Post Market Clinical Follow-Up
• Support complaints investigation and report completion, including cybersecurity issues from post-market
• Support extra-EU registration
• Coordinate and collaborate with cross-functional teams, including Management, Operations, and Sales Team

Required Qualifications:

• 3+ years of experience in similar roles in the Medical Device field, with expertise in Quality Assurance and/or Regulatory Affairs
• Knowledge of international and local MD regulations
• Understanding of Quality Management System requirements, Risk management principles, Regulatory requirements
• Familiarity with 21 CFR Part 820, ISO 13485, ISO 14971 and Product Risk Management
• V&V requirements
• Experience with post-market surveillance
• Technical skills related to medical device industry processes
• Experience in developing/reviewing manufacturing process maps and FMEA, identifying critical points and process validation protocols (IQ-OQ-PQ) and writing summary reports
• Experience dealing with the FDA
• Strong analytical skills and ability to work in a structured and concise manner
• Effective written and verbal communication in English
• Knowledge of MDR 2017/745 is a plus
• Authorized to work in the United States (or holds valid documentation if placed via third-party agency)

Next Steps

Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview.

If there's a positive match, a technical interview with the Hiring Manager will be arranged.

In the case of a positive outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal.

Alternatively, if the outcome is negative, we will contact you to halt the recruitment process.

Working at PQE Group

As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world.

If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you.

Apply now and take the first step towards an amazing future with us.