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Technical Responsible for Medical Device Manufacturing
hace 3 semanas
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.Antes de solicitar este puesto, por favor, lea la siguiente información sobre esta oportunidad que encontrará a continuación.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 StepsUpon 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 GroupAs a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. xohynlm 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.
