Senior Quality Engineer – MedTech, ISO 13485 Expert

Arevna Limited; West Midlands; Vor Ort; GBP 55.000 - 75.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

QMS Leadership

Risk Management

CAPA Investigations

Root Cause Analysis

Supplier Quality

Process Validation

Audits & Compliance

Data Driven Improvement

Jobbeschreibung

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.