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 **
, with
40 subsidiaries
and more than
employees in Europe, Asia and the Americas
.
We are looking for an experienced
Quality Assurance & Regulatory Affairs (QARA) professional
to support a Medical Device organization. In this role, you will act as an extension of the manufacturer's Quality and Regulatory team, helping to maintain compliance with applicable regulatory and quality standards, including
EU MDR **
,
ISO *
,
ISO **
, and
ISO *
.
This is an excellent opportunity for a hands-on quality and regulatory expert who enjoys working in a dynamic MedTech environment and collaborating across multiple stakeholders.
Responsibilities include:
Maintain and continuously improve the Quality Management System (QMS).
Update quality documentation, procedures, forms, and records.
Manage non-conformities, CAPAs, deviations, and change controls.
Plan, coordinate, and conduct internal audits.
Support external audits and inspections, including ISO *, ISO , ISO *, Competent Authorities, and customers.
Follow up on audit findings and corrective actions.
Support Management Reviews and quality performance monitoring.
Assist with supplier quality management.
Support complaint handling, vigilance, and post-market surveillance.




Maintain regulatory documentation for distributed medical devices and support product launches.
Support the Technical Responsible Person for Distribution with technical documentation and AEMPS/RECOPS registrations.
Requirements:
Degree in Life Sciences, Engineering, Pharmacy, Quality, or a related field.
Minimum 3 years of experience in Quality Assurance and/or Regulatory Affairs within the medical device industry.
Good knowledge of EU MDR ** and ISO *, ISO **, and ISO *.
Experience in QMS maintenance, audits, CAPAs, deviations, change controls, and non-conformity management.
Familiarity with complaint handling, vigilance, and post-market surveillance.
Willingness to travel.
Next Steps
Upon receiving your application, if a match is found, the Recruiting Department will contact you for an initial HR interview. If successful, a technical interview with the project stakeholders will be arranged. Following a positive outcome, our recruitment team will discuss the next steps and contractual details.
Working at PQE Group
As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration, innovation, and professional growth. PQE Group offers the opportunity to work on international projects, develop specialized expertise, and collaborate with industry-leading pharmaceutical companies worldwide.
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📌 Quality Assurance (España)
🏢 Pqe Group
📍 España