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
Salary description
£40000.00 - £44000.00 per year