Medical Device Standards & QA Compliance Specialist

Terumo Aortic; Scotland; On-site; GBP 40,000 - 60,000; Full time

Job summary

A medical device company in the United Kingdom is seeking a Standards Compliance Quality Specialist to join their External Quality team. The successful candidate will monitor and evaluate standards impacting product compliance and collaborate with various departments to integrate compliance into product design. They should possess a degree in Science or Engineering, strong analytical skills, and in-depth knowledge of FDA and ISO regulations. This role offers an opportunity to influence quality assurance in a dynamic regulatory environment.

Qualifications

• Degree in Science/Engineering or equivalent background required.
• Knowledge of Class III medical devices is desirable.
• In-depth knowledge of medical device regulations and standards required.

Responsibilities

• Monitor and evaluate new standards for product impact.
• Ensure ongoing compliance of products throughout lifecycle.
• Facilitate closure of compliance actions.

Skills

Analytical skills

Problem-solving skills

Communication skills

Knowledge of FDA regulations

Knowledge of ISO standards

Experience with QMS tools

Education

Degree in Science/Engineering

Tools

Microsoft Office

QA systems

Job description

A medical device company in the United Kingdom is seeking a Standards Compliance Quality Specialist to join their External Quality team. The successful candidate will monitor and evaluate standards impacting product compliance and collaborate with various departments to integrate compliance into product design. They should possess a degree in Science or Engineering, strong analytical skills, and in-depth knowledge of FDA and ISO regulations. This role offers an opportunity to influence quality assurance in a dynamic regulatory environment.