Quality Engineer - Medical Devices & Precision Manufacturing - Rotherham

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–Thu 7:00 am–3:30 pm | Fri 7:00 am–2:30 pm