Job Title: Senior Quality Engineer (Medical Devices)
Location: Midlands UK (On-site)
Employment Type: Full-time, Permanent
Role Overview
An innovative, fast-growing medical technology company focused on cutting-edge joint preservation and surgical solutions is seeking an experienced Senior Quality Engineer.
Based at their facility in the Midlands you will play a pivotal role in driving product quality, process compliance, and continuous improvement across the full product lifecycle. Working closely with R&D, manufacturing, and regulatory teams, you will champion adherence to ISO 13485, EU MDR / UK MDR, and global market requirements to support ongoing growth.
Key Responsibilities
- QMS Leadership & Risk Management: Lead and strengthen key Quality Management System (QMS) processes, including Change Control, Document Control, CAPA lifecycle management, and ISO 14971 risk management.
- CAPA & Root Cause Investigations: Own complex non-conformance (NCR) and CAPA investigations, utilising structured problem-solving methodologies (e.g., 8D, 5 Whys, Fishbone) to drive sustainable corrective actions.
- Supplier & Manufacturing Quality: Oversee supplier performance, qualification, and audits; review critical manufacturing batch records, sterilisation validation data, and incoming component compliance.
- Product Release & Process Validation: Support design transfer, process validation (IQ/OQ/PQ), and final batch release protocols, ensuring swift isolation and resolution of non-conforming product.
- Audits & Post-Market Surveillance: Plan and lead internal audits, assist with Notified Body / UK Approved Body surveillance audits, and support PMS and complaint investigation data analysis.
- Data Trending & Continuous Improvement: Monitor and present quality KPIs, driving data-led operational enhancements, scrap reduction, and right-first-time manufacturing initiatives.
Candidate Profile & Requirements
- Industry & Standards Expertise: Proven Quality Engineering background within the medical device sector ( surgical devices highly advantageous).
- Regulatory Depth: In-depth working knowledge of ISO 13485:2016, ISO 14971, and EU MDR / UK MDR compliance requirements.
- Technical Problem Solving: Demonstrated track record leading root-cause investigations, CAPA management, and process/design change assessments.
- Auditing & Validation Experience: Internal auditor experience (lead auditor certification a plus) and familiarity with process/sterilisation validation.
- Collaborative Mindset: Strong cross-functional leadership skills, high attention to detail, and the commercial pragmatism needed in an agile, expanding MedTech environment.
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