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Technical Responsible for Medical Device Manufacturing

hace 3 semanas


Bilbao, España PQE Group A tiempo completo

Are you ready to join aworld leaderin the exciting and dynamic fields of thePharmaceutical and Medical Device industries? PQE Grouphas been at the forefront of these industriessince 1998, with40 subsidiariesand more than2000 employees in Europe, Asia and the Americas. As part of our ongoing growth and commitment to excellence, we are currently looking for aTechnical Responsible for Medical Device Manufacturingto 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 usingliquid nitrogen for cryopreservation and tissue conservation.Responsibilities include, but are not limited to: Provide support inplant authorizationprocesses and ensure adherence toregulatory requirementsfor medical device manufacturing. Review finished products and decide on theirreleaseorrejectionbased on established quality and regulatory criteria, specifically for products involvingliquid nitrogenused incryopreservationandtissue conservation. Coordinate and performqualification and validation activitiesfor facilities, equipment, and related processes. Maintain accurate documentation and support the implementation and continuous improvement of theQuality Management Systemin accordance with medical device regulations(such as ISO 13485 and EU MDR). Offertechnical guidanceto production and quality teams, ensuring that manufacturing processes remain compliant and efficient.Required Qualifications: Previous experienceworking with medical devices involvingliquid nitrogen, specifically forcryopreservationandtissue conservation. Degree in Engineering, Biotechnology, Life Sciences, Pharmacy, or related fields. Solid understanding ofmedical device regulatory requirementsandquality systems. Experience inqualificationandvalidationactivities. 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 achallenging, 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.