{"@context":"https://schema.org","@type":"JobPosting","title":"Quality Assurance Specialist","description":"

Role: Senior Quality Assurance Specialist | Medical Devices | 6-Month Contract

Role:

Senior Quality Assurance Specialist | Medical Devices | 6-Month Contract

Company: Arevna

Company:

Arevna

Location: West Midlands, United Kingdom (On-site)

Location:

West Midlands, United Kingdom (On-site)

Type: 6-Month Contract (Outside IR35)

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.

NCR & CAPA Ownership: Lead the end-to-end investigation, remediation, and closure of critical Non-Conformance Reports (NCRs) and oversee complex CAPA lifecycles.

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.

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.

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.

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.

Design & Risk Assurance:

Partner with cross-functional engineering and manufacturing teams on engineering changes, design verification, and ISO 14971 risk management files.

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)

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)

Engagement Details

Duration: 6 Months (with potential extension)Working Model: On-siteRate: Competitive daily rate (Inside IR35)Start Date: Immediate / Up to 2-3 weeks notice

Duration: 6 Months (with potential extension)

Duration:

6 Months (with potential extension)

Working Model: On-site

Working Model:

On-site

Rate: Competitive daily rate (Inside IR35)

Rate:

Competitive daily rate (Inside IR35)

Start Date: Immediate / Up to 2-3 weeks notice

Start Date:

Immediate / Up to 2-3 weeks notice

If you are an established contractor ready for your next project, drop me a direct message on LinkedIn or connect to arrange a confidential discussion.

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