Senior Quality Engineer

Job Title: Senior Quality Engineer (Medical Devices)

Location: Midlands UK (On-site)

Employment Type: Full-time, Permanent

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.

• 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.

• 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 Med Tech environment.