QUALITY ENGINEER
Location: Lancashire
Hours: 35 hours per week (Mon–Thu 08:30–17:00, Fri 08:30–13:30)
Industry: Medical Devices / Advanced Manufacturing
About The Role
Are you a meticulous, motivated Quality Engineer looking to make a real impact in a growing, high-tech medical manufacturing environment? We are a leading producer of orthopedic components and polymeric materials, supplying high-specification products to the medical industry worldwide. With ongoing business growth, we are seeking a skilled Quality Engineer to join our expanding Quality Department.
This is an exciting opportunity to contribute to world-class manufacturing standards, support innovation, and help drive continuous improvement across our operations.
Role and Responsibilities
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Making risk-based decisions to drive product and process quality.
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Leading and supporting root cause analysis (RCA) and CAPA activities.
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Mentoring Quality Controllers and Inspectors, providing training and coaching.
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Leading process improvement, validation activities, and Lean initiatives.
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Designing and conducting MSA, Gauge R&R, sampling plans, and capability studies.
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Interpreting customer requirements and ensuring full compliance.
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Preparing clear and insightful quality metrics and reports for management.
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Developing PFMEAs, risk assessments, engineering change controls and documentation.
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Supporting New Product Introduction (NPI) projects.
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Liaising with customers and leading escalations when required.
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Conducting internal and supplier audits to ISO and customer standards.
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Ensuring promotion of quality and regulatory awareness across the company.
What You Need toSucceed
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Qualification in Quality or Mechanical Engineering (ONC/HNC/Degree) or equivalent.
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Experience in a Quality-focused role within medical, automotive, or similar regulated industries.
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Strong working knowledge of QMS principles and standards (ISO 9001, ISO 13485, ISO 17025, ISO 14001, ISO 45001, FDA QSRs, MDD).
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Skilled in FMEA, root cause analysis, Lean/Six Sigma tools, and process flows.
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Competent in Process Validation, MSA, and Gauge R&R.
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Able to interpret complex technical drawings.
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Internal auditing experience to recognised standards.
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Methodical, conscientious, and an effective communicator.
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Excellent time-management and the ability to multitask.
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Strong written communication and computer literacy.
What's in it for You?
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Work with cutting-edge materials and technologies in the medical sector.
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Contribute to life-changing products that support patient well-being globally.
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Be part of a supportive, technically strong team with opportunities to grow.
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Enjoy a balanced 35-hour working week with an early finish every Friday