Senior Quality Engineer

Arevna Limited; West Midlands; In loco; GBP 55.000 - 75.000; Tempo pieno

Descrizione del lavoro

Arevna Limited in the Midlands is seeking a Senior Quality Engineer to drive quality across the full lifecycle of medical devices. You will champion ISO 13485, EU MDR/UK MDR compliance, and regulatory alignment while collaborating with R&D, manufacturing, and regulatory teams.

You will lead CAPA and NCR investigations, manage QMS changes, and oversee supplier quality and process validation to ensure compliant product releases and continuous improvement.

Competenze

• Proven Quality Engineering background in medical devices.
• Strong regulatory knowledge of ISO 13485, ISO 14971, EU MDR/UK MDR.
• Experience leading CAPA and root-cause investigations.
• Auditing and validation experience within a MedTech context.

Mansioni

• Lead QMS processes including Change Control and Document Control.
• Own CAPA lifecycle and NCR investigations using structured problem-solving.
• Oversee supplier quality, audits, and manufacturing batch record reviews.
• Support product release, process validation, and final batch release activities.
• Plan and lead internal and external audits and PMS data analyses.
• Track quality KPIs and drive continuous improvement initiatives.

Conoscenze

QMS Leadership

Risk Management

CAPA Investigations

Root Cause Analysis

Supplier Quality

Process Validation

Audits & Compliance

Data Driven Improvement

Descrizione del lavoro

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.