Quality Systems Leader - Medical Devices & Compliance

Nissha Medical Technologies, Ltd.; Paignton; On-site; GBP 50,000 - 70,000; Full time

Job summary

A leading medical technology company in the United Kingdom is seeking a Quality Manager to oversee the implementation of their Quality Management System and ensure compliance with various regulatory standards, including ISO 13485. The ideal candidate will have at least three years of experience in a regulated medical device environment, with strong supervisory skills. Responsibilities include managing Quality KPIs, conducting audits, and maintaining compliance throughout the product lifecycle. Excellent benefits and opportunities for professional development are offered.

Qualifications

• Three years’ experience in an ISO 13485 regulated environment.
• Supervisory experience preferred.
• Proficient in Microsoft Office.

Responsibilities

• Implement and manage the Quality Management System.
• Develop and track Quality KPIs.
• Write and review Standard Operating Procedures.
• Oversee internal and external audits.
• Act as primary interface with regulatory agencies.

Skills

Experience in ISO 13485 medical device environment

Process improvement methods

Understanding of regulations and standards

Supervisory experience

Knowledge of cGMP and validation

Operation of related instrumentation

Documentation-related databases

Microsoft Office (Word and Excel)

Education

Bachelor's degree in Business, Science, or Engineering

Master's degree

CQM Certification

Job description

A leading medical technology company in the United Kingdom is seeking a Quality Manager to oversee the implementation of their Quality Management System and ensure compliance with various regulatory standards, including ISO 13485. The ideal candidate will have at least three years of experience in a regulated medical device environment, with strong supervisory skills. Responsibilities include managing Quality KPIs, conducting audits, and maintaining compliance throughout the product lifecycle. Excellent benefits and opportunities for professional development are offered.