Technical Responsible for Medical Device Manufacturing

PQE Group; Bilbao; Presencial; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

A leading multinational in pharmaceuticals is seeking a Technical Responsible for Medical Device Manufacturing in Bilbao, Spain. This role involves ensuring compliance with regulatory standards and maintaining high-quality production of medical devices. Ideal candidates will have experience with liquid nitrogen used in cryopreservation and a background in related fields such as engineering or biotechnology. Opportunities exist for working on international projects within a diverse team. Join us and take the first step toward a rewarding career.

Servicios

Opportunity to work on international projects

Collaborative and multicultural work environment

Formación

• Experience in qualification and validation activities.
• Solid understanding of medical device regulatory requirements and quality systems.
• Proficiency in English; Spanish is an advantage.

Responsabilidades

• Provide support in plant authorization processes and ensure compliance with regulations.
• Review finished products for quality and regulatory adherence.
• Coordinate qualification and validation activities for processes.
• Maintain documentation for Quality Management System as per ISO 13485 and EU MDR.
• Offer technical guidance to production and quality teams.

Conocimientos

Experience with medical devices involving liquid nitrogen

Strong analytical and problem-solving skills

Ability to collaborate effectively with cross-functional teams

Attention to detail

Educación

Degree in Engineering, Biotechnology, Life Sciences, or Pharmacy

Descripción del empleo

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

• 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.