Quality Engineer - Medical Devices & Compliance

Advanced Medical Solutions; Plymouth; On-site; GBP 55,000 - 75,000; Full time

Job summary

Advanced Medical Solutions is seeking a Quality Improvement professional to drive continual improvement and regulatory compliance across the business. You will work with Manufacturing, Supply Chain, Quality and R&D to enhance processes, reduce non-conformances and ensure risk-based decision making.

The role requires a degree in engineering or science, a Certified Quality Auditor credential, and experience in a regulated medical device environment.

Qualifications

• Degree in Engineering, Microbiology or Chemistry, or equivalent experience.
• Certified Quality Auditor is essential; Lead Auditor preferred.
• Experience in a regulated medical device environment (ISO 13485).
• Strong knowledge of risk management per ISO 14971 and MDSAP requirements.
• Excellent communication and ability to work autonomously in a multi-disciplinary team.

Responsibilities

• Timely resolution of non-conformances and implementing corrective actions.
• Lead and conduct internal quality audits and reviews.
• Develop and maintain QMS documentation and SOPs.
• Support supplier audits and external regulatory inspections.
• Drive continuous improvement and reduction of non-conformances.
• Provide quality input to new product developments and changes.

Skills

Quality auditing

Root cause analysis

Risk management

Regulatory knowledge

Communication skills

Education

Engineering degree

Microbiology/Chemistry related

Tools

MS Word

MS Excel

MS PowerPoint

MS Project

Lotus Notes

ERP systems

Job description

Advanced Medical Solutions is seeking a Quality Improvement professional to drive continual improvement and regulatory compliance across the business. You will work with Manufacturing, Supply Chain, Quality and R&D to enhance processes, reduce non-conformances and ensure risk-based decision making.

The role requires a degree in engineering or science, a Certified Quality Auditor credential, and experience in a regulated medical device environment.