Technical Responsible for Medical Device Manufacturing

PQE Group; Madrid; Presencial; EUR 30.000 - 50.000; Jornada completa

Descripción de la vacante

A leading medical device manufacturer in Madrid is looking for a Technical Responsible for Medical Device Manufacturing. This role involves overseeing compliance with regulatory standards, providing technical guidance to production teams, and reviewing finished products for quality assurance. Candidates should have a degree in relevant fields and experience with medical devices involving liquid nitrogen. Proficiency in English is required, with Spanish as an advantage. Join a company that works on international projects and offers skill enhancement opportunities.

Formación

• Experience with medical devices involving liquid nitrogen for cryopreservation.
• Solid understanding of medical device regulations.
• Technical guidance to production and quality teams.

Responsabilidades

• Support plant authorization processes for medical device manufacturing.
• Review finished products to decide on their release or rejection.
• Maintain documentation and improve the Quality Management System.
• Ensure compliance and efficiency in manufacturing processes.

Conocimientos

Working with medical devices involving liquid nitrogen

Understanding of regulatory requirements

Proficiency in English

Knowledge of ISO 13485

Educación

Degree in Engineering, Biotechnology, Life Sciences, Pharmacy

Descripción del empleo

Overview

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? 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.

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.
• 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.

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.
• Proficiency in English; Spanish is an advantage.

Selection Process

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. If the outcome is positive, the 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.

Opportunity

PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world.