Medical Device Quality Assurance Expert

beBeeQuality; Tarragona; A distancia; EUR 30.000 - 50.000; Jornada completa

Descripción de la vacante

A leading medical device firm is seeking a Medical Device Quality Assurance Expert to lead quality management systems and manage external audits. The ideal candidate has extensive knowledge of Medical Device Regulations and ISO standards. Excellent English communication skills are essential. This is a remote role requiring a valid work permit for the candidate's country of residence.

Servicios

Supportive and inclusive work environment

Professional growth opportunities

Formación

• Extensive knowledge of Medical Device Regulations (MDD, MDR, IVDR).
• Experience in Quality Assurance or Regulatory assurance on a global or multi-site scale.
• Excellent interpersonal and communication skills.

Responsabilidades

• Centralize and oversee the implementation of Lean and compliant Quality Management systems.
• Manage external audits and interactions with regulatory bodies.
• Coordinate activities with auditing organizations.
• Oversight and management of all medical devices processes.

Conocimientos

Medical Device Regulations knowledge

ISO13485

ISO17021

MDSAP

Interpersonal skills

Fluency in English

Descripción del empleo

Medical Device Quality Assurance Expert

We are seeking a highly skilled professional to lead our medical device quality management system.

Responsibilities

• Centralize and oversee the implementation of Lean and compliant Quality Management systems for medical devices.
• Manage external audits and interactions with regulatory bodies.
• Coordinate activities with auditing organizations.
• Oversight and management of all medical devices processes, including quality management reviews and impartiality.

The ideal candidate will have extensive knowledge of Medical Device Regulations (MDD, MDR, IVDR) and ISO13485, ISO17021, and MDSAP. They will also possess experience in Quality Assurance or Regulatory assurance on a global or multi-site scale. Excellent interpersonal and communication skills, including fluency in English, are essential.

Environment & Qualifications

We offer a supportive and inclusive work environment that fosters professional growth and personal development. This role is remote-based, requiring the candidate to hold a valid work permit for their country of residence.