Arevna
Quality Assurance Specialist
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Role: Senior Quality Assurance Specialist | Medical Devices | 6-Month Contract
Company: Arevna
Location: West Midlands, United Kingdom (On-site)
Type: 6-Month Contract (Outside IR35)
Are you a senior QA professional available for an immediate or short-notice contract?
Arevna is currently supporting an innovative, fast-growing medical devices client based in West Midlands that requires an experienced Senior Quality Assurance Specialist for an initial 6-month engagement to provide key project support and QA leadership.
Key Responsibilities
- NCR & CAPA Ownership: Lead the end-to-end investigation, remediation, and closure of critical Non-Conformance Reports (NCRs) and oversee complex CAPA lifecycles.
- Root Cause Analysis: Drive advanced problem-solving techniques (5-Why, Fishbone, 8D) across manufacturing, product design, and supplier quality issues.
- QMS Remediation & Maintenance: Lead targeted improvements and maintenance for the ISO 13485 Quality Management System to ensure full audit readiness.
- Audit Execution: Lead internal audits, support supplier quality evaluations, and assist in preparation for upcoming Notified Body surveillance audits.
- Design & Risk Assurance: Partner with cross-functional engineering and manufacturing teams on engineering changes, design verification, and ISO 14971 risk management files.
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What We Are Looking For
- Proven track record as a Quality Specialist / Senior Quality Engineer within regulated medical devices.
- Deep hands-on working knowledge of ISO 13485 and ISO 14971 (MDR knowledge is advantageous).
- Proven capability to hit the ground running with minimal oversight on CAPA and audit readiness workstreams.
- Lead Auditor certification (ISO 13485)
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Engagement Details
- Duration: 6 Months (with potential extension)
- Working Model: On-site
- Rate: Competitive daily rate (Inside IR35)
- Start Date: Immediate / Up to 2-3 weeks notice
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