Senior Medical Device Quality Manager

beBeeQuality; Madrid; A distancia; EUR 50.000 - 70.000; Jornada completa

Descripción de la vacante

A leading medical device company is seeking a Senior Quality Assurance professional as a Medical Device Quality Manager. This remote role emphasizes managing a compliant Quality Management system for medical device products. Candidates should have extensive experience and qualifications in medical device regulations, complemented by excellent communication and organizational skills. The position offers a competitive salary, flexible schedule, and numerous opportunities for career advancement.

Servicios

Career advancement opportunities

Flexible schedule and hybrid model

Continuous learning and professional growth

Multinational environment

Benefits platform with discounts

Formación

• Minimum 5 years experience in Quality Assurance or Regulatory assurance.
• Experience in team management with at least 2 years in the role.
• Medical device training is required.

Responsabilidades

• Manage external audits and communication with authorities.
• Maintain accreditation under MDSAP, ISO 13485, UKCA.
• Coordinate complaints and regulatory requests.

Conocimientos

Knowledge of Medical Device Regulations

Excellent interpersonal skills

Organizational skills

Fluency in English

Educación

Higher education qualification in life/natural sciences

Descripción del empleo

Overview

We are seeking a senior Quality Assurance professional to join our team as Medical Device Quality Manager. In this role, you will be responsible for ensuring the quality of our medical device products and services. Your primary focus will be on managing a Lean and compliant Quality Management system for medical devices schemes, including Notified Body NB1639, UKCA, ISO 13485, MDSAP, and other relevant schemes.

Responsibilities

• Managing external audits and communication with competent authorities
• Managing internal audits and communication with relevant departments
• Maintaining designation under MDR / IVDR and supporting the development and designation under new schemes
• Maintaining accreditation under MDSAP, ISO 13485, and UKCA and supporting the development of other new schemes
• Coordinating all activities with auditing organizations (Belgian and English competent authority, UKAS, etc.)
• Coordinating all complaints and regulatory requests (CEF) to provide customers and CA with appropriate answers

This role will report to the Head of Certification and Compliance, Business Assurance. It is remote-based, and we are open to candidates located anywhere across Europe, provided they hold a valid work permit for their country of residency.

Qualifications

• Strong knowledge of Medical Device Regulations (MDD, MDR, IVDR) and ISO 13485, ISO 17021, and MDSAP
• Excellent interpersonal and communication skills, including fluency in English
• Strong organizational skills and flexibility
• At least 5 years\' experience in Quality Assurance or Regulatory assurance on a global or multi-site scale gained in a Notified Body organization
• Experience in team management, preferably with a minimum of 2 years\' experience
• A higher education qualification in a relevant life / natural sciences subject and completed medical device training

Benefits

In return, you can expect a competitive salary and benefits package, including :

• A stable and growing company with opportunities for career advancement
• A flexible schedule and hybrid model
• Opportunities for continuous learning and professional growth through our SGS University and Campus
• A multinational environment with colleagues from multiple continents
• A benefits platform offering various perks and discounts

If you are a motivated and experienced Quality Assurance professional looking for a new challenge, please submit your CV in English. We look forward to hearing from you!