Quality Engineer – Medical Devices & Regulatory Compliance

Advanced Medical Solutions; Plymouth; On-site; GBP 42,000 - 64,000; Full time

Job summary

Advanced Medical Solutions is a world-leading developer and manufacturer of medical device technology, delivering quality outcomes for patients and value for payers. The role focuses on improving processes, maintaining quality compliance, and supporting regulatory requirements across the business.

You will work with Manufacturing, Supply Chain, Quality, and R&D to identify improvements, manage risks, and train staff in quality and regulatory practices.

Qualifications

• Requires degree level in Engineering, Microbiology, Chemistry or associated fields, or equivalent industry experience.
• Experience in design, manufacturing or quality engineering position (Medical Device experience preferred).
• Certified Quality Auditor (essential), Lead Auditor (preferred).
• Working knowledge of risk management, risk assessment tools & techniques and reporting in accordance with ISO 14971 (essential).
• Excellent communication skills; written, verbal and presenting (essential).
• Able to manage own time effectively, prioritise tasks and deliver to critical deadlines (essential).

Responsibilities

• Timely resolution of identified non-conformances and implementation of effective corrective action to prevent recurrence.
• Identification of potential areas of non-conformance and timely action to prevent occurrence.
• Reduction in product, process and Quality Management System non-conformances, plus Customer Complaints.
• Timely implementation of product, process and Quality Management System changes.
• Develop, generate and maintain documentation to support an effective and compliant Quality Management System, including: Product and Process FMEAs / Risk Assessments
• Quality Systems and Process SOPs and Work Instructions
• Root cause analysis and problem solving for identified nonconformities and facilitate implementation of actions to increase efficiency and further enhance product reliability.
• Conduct supplier audits, monitor and measure supplier performance.
• Review and approval of validation deliverables.
• Represent AMS Ltd professionally to external customers, suppliers and regulatory bodies.

Skills

Quality Assurance

Regulatory Compliance

Continuous Improvement

Root Cause Analysis

Auditing

Quality Management

Education

Engineering Degree

Chemistry Degree

Microbiology Degree

Tools

Microsoft Excel

ERP systems

Job description

Advanced Medical Solutions is a world-leading developer and manufacturer of medical device technology, delivering quality outcomes for patients and value for payers. The role focuses on improving processes, maintaining quality compliance, and supporting regulatory requirements across the business.

You will work with Manufacturing, Supply Chain, Quality, and R&D to identify improvements, manage risks, and train staff in quality and regulatory practices.