Senior Quality Engineer: Medical Device Risk & Regulatory Lead

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

Job summary

A medical device company is seeking a Senior Quality Engineer specializing in risk management. You will lead essential risk management activities and ensure compliance with regulatory standards. The ideal candidate holds a degree in Science/Engineering, has strong analytical skills, and is familiar with medical device regulations. Experience with risk and field management in a regulated environment is essential. This role offers the opportunity to influence quality and assurance processes within a dynamic Quality Assurance team.

Qualifications

• In-depth knowledge of FDA, ISO, EU MDR regulations.
• Experience managing risk and field activities in medical device industry.
• Certification such as CQE, CQA, or Lead Auditor is highly desirable.
• Ability to independently influence change.

Responsibilities

• Lead risk management activities including HHEs and FSCAs.
• Ensure compliance with country-specific regulations.
• Provide regulatory knowledge and support across functions.
• Conduct internal and external audits.
• Provide training on risk management standards.

Skills

Risk management

Regulatory compliance

Analytical skills

Problem-solving

Communication skills

IT technology competence

Education

Degree in Science/Engineering

Tools

QMS tools

Document control systems

Job description

A medical device company is seeking a Senior Quality Engineer specializing in risk management. You will lead essential risk management activities and ensure compliance with regulatory standards. The ideal candidate holds a degree in Science/Engineering, has strong analytical skills, and is familiar with medical device regulations. Experience with risk and field management in a regulated environment is essential. This role offers the opportunity to influence quality and assurance processes within a dynamic Quality Assurance team.