Technical Medical Device Manufacturing

Puesto: Technical Responsible for Medical Device Manufacturing
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  Technical Responsible for Medical Device Manufacturing   to support the production of high-quality medical devices and ensure compliance with regulatory and quality standards. The ideal candidate will bring solid experience with medical devices, particularly those using  liquid nitrogen for cryopreservation and tissue conservation  .

Responsibilities include, but are not limited to:
Provide support in  plant authorization   processes and ensure adherence to  regulatory requirements   for medical device manufacturing.
Review finished products and decide on their  release   or  rejection   based on established quality and regulatory criteria, specifically for products involving  liquid nitrogen   used in  cryopreservation   and  tissue conservation  .
Coordinate and perform  qualification and validation activities   for facilities, equipment, and related processes.
Maintain accurate documentation and support the implementation and continuous improvement of the  Quality Management System   in accordance with medical device regulations  (such as ISO 13485 and EU MDR)  .
Offer  technical guidance   to production and quality teams, ensuring that manufacturing processes remain compliant and efficient.

Required Qualifications:

Previous experience   working with medical devices involving  liquid nitrogen  , specifically for  cryopreservation   and  tissue conservation  .
Degree in Engineering, Biotechnology, Life Sciences, Pharmacy, or related fields.
Solid understanding of  medical device regulatory requirements   and  quality systems  .
Experience in  qualification   and  validation   activities.
Strong analytical and problem-solving skills, with excellent attention to detail.
Ability to collaborate effectively with cross-functional teams.
Proficiency in English;
Spanish is an advantage.

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.