Cure Talent are delighted to be partnered with a specialist medical manufacturer supplying high-precision orthopaedic components to the global medical device industry. As the business continues to grow, we have an opportunity for a Quality Engineer to join an established Quality team and play a key role in supporting manufacturing excellence and continuous improvement.
As the new Quality Engineer, you will operate in a hands-on role across quality engineering, process improvement, validation and audit activity. Working closely with production, engineering, suppliers and customers, you will support robust quality performance while mentoring and developing quality colleagues.
Key Responsibilities
* Apply risk-based decision making to quality and process issues across manufacturing.
* Support and mentor Quality Controllers and Inspectors, including training in root cause analysis and CAPA.Author, review and approve RCA, CAPA and wider QMS documentation.
* Lead and support process improvement and validation activities, including PFMEAs and risk assessments.
* Design and conduct gauge R&R, MSA, process capability and statistical analysis studies.
* Support NPI activity, engineering change control and process transfers.
* Analyse and present quality metrics and performance data to management.
* Act as a point of escalation for customer quality issues and support customer engagement.
* Conduct internal and supplier audits to agreed schedules.
* Support lean manufacturing and continuous improvement initiatives.
Experience and Skills Required
* Quality or Mechanical Engineering qualification (ONC, HNC, Degree or equivalent).
* Experience working in a quality or quality engineering role within a regulated manufacturing environment.
* Strong knowledge of quality systems and standards, including ISO 9001, ISO 13485 and GMP.
* Experience with quality tools such as FMEA, root cause analysis, CAPA, lean and Six Sigma methodologies.
* Experience with MSA, GR&R, process validation and statistical analysis.
* Ability to interpret complex technical drawings and specifications.
* Background in medical devices or automotive manufacturing is advantageous.
If you’re a Quality Engineer looking for a technically varied role within a specialist medical manufacturing environment, we’d love to hear from you