Quality Engineer - Medical Devices & Precision Manufacturing - Rotherham

Vested Talent; Rotherham; On-site; GBP 42,000 - 56,000; Full time

Job summary

Vested Talent is recruiting a Quality Engineer for a precision engineering manufacturer in the UK, serving medical devices, aerospace and regulated sectors.

The role focuses on supporting the QARA function, maintaining the QMS, and coordinating external audits, while providing hands-on quality support across manufacturing.

You will work with the Quality Manager and cross-functional teams to drive CAPA and continuous improvement initiatives.

Qualifications

• Background in QA and/or Regulatory Affairs within a regulated manufacturing environment.
• Strong understanding of Quality Management Systems (QMS) and quality compliance.
• Experience supporting external audits, certification bodies and/or regulatory bodies.
• Strong Excel skills, including creating formulas and using data to produce reports.
• Experience with CAPA, non-conformance management and root-cause analysis.
• Experience with batch release, product disposition and traceability.
• Ability to read engineering drawings and specifications.

Responsibilities

• Support the QARA function across the site and manufacturing process.
• Maintain and improve the Quality Management System (QMS) and prepare for audits.
• Coordinate external audits and follow-up of corrective actions.
• Investigate internal non-conformances and lead CAPA activities.
• Review drawings, specifications, inspection records and CMM reports.
• Assist with batch-release and traceability activities.
• Drive continuous improvement with production and engineering teams.

Skills

Quality Assurance

Regulatory Affairs

QMS

Audits

CAPA

Root Cause Analysis

Batch Release

Reading Drawings

Metrology

Excel

Power BI

ERP/MRP

Tools

Power BI

ERP/MRP systems

Excel

CMM reports

Job description

We are recruiting a Quality Engineer for an established precision engineering manufacturer producing high-value, quality-critical components for medical devices, aerospace, defence and other regulated sectors.

This is a newly created role within a close-knit manufacturing business, offering direct access to the Quality Manager and genuine scope to improve processes, influence standards and introduce better ways of working. The company is also part of a growing group of specialist engineering and medical-technology businesses.

The role will primarily support the site's Quality Assurance & Regulatory Affairs (QARA) function, with a strong focus on maintaining compliance, supporting the Quality Management System (QMS), managing external audits and working with external certification and regulatory bodies. Alongside this, you will provide hands-on quality support across the manufacturing operation.

Your role

You will support quality and compliance across the full manufacturing process, from incoming materials and supplier documentation through to production, inspection and batch release.

Working closely with the Quality Manager and wider QARA function, you will help maintain and improve the site's QMS, support regulatory and compliance activities, and ensure the business remains prepared for external audits and certification requirements.

You will also work closely with Production, Engineering, Inspection, suppliers and customers to identify quality issues, implement corrective actions and drive continuous improvement.

Key responsibilities will include:

• Supporting the Quality Assurance & Regulatory Affairs (QARA) function across the site
• Supporting the maintenance, development and continuous improvement of the Quality Management System (QMS)
• Supporting regulatory and compliance activities within a regulated manufacturing environment
• Supporting and coordinating external audits, including preparation, hosting and follow-up of corrective actions
• Supporting the management and ongoing relationship with external certification, regulatory and other relevant bodies
• Supporting internal, customer, supplier and third-party audits
• Investigating internal and customer non-conformances
• Leading root-cause analysis and CAPA activities
• Supporting goods-inwards inspection and supplier-quality improvements
• Making practical disposition decisions on non-conforming products
• Reviewing drawings, specifications, inspection records and CMM reports
• Completing batch-release and traceability activities
• Maintaining and improving procedures, work instructions and controlled quality records
• Analysing KPIs and quality trends to identify improvement opportunities
• Working closely with production, engineering and inspection teams to reduce defects and improve right-first-time performance
• Supporting the ongoing development of quality processes, standards and best practice across the site

What you will bring:

• A Quality Assurance and/or Regulatory Affairs background within a regulated manufacturing environment
• Strong understanding of Quality Management Systems (QMS) and quality compliance
• Experience supporting external audits, certification bodies and/or regulatory bodies
• Strong Excel skills, including creating formulas and using data to produce reports
• Experience with CAPA, non-conformance management and root-cause analysis
• Experience with batch release, product disposition and traceability
• Ability to read engineering drawings and specifications
• Knowledge of manufacturing inspection methods and standard metrology equipment
• Experience with internal audits
• Experience writing and maintaining controlled quality documentation
• Confident communication skills, with the ability to work effectively with production teams, suppliers, customers and external bodies
• Experience of CNC machining, AS9100, ISO 9001, ERP or MRP systems, Power BI, Lean, Six Sigma or GMP would be advantageous but is not essential.

Mon-Thur 7:00 am-3:30 pm | Fri 7:00 am-2:30 pm