Quality Engineer

Zenith Advisory Partners; Bacup; On-site; GBP 80,000 - 100,000; Full time

Job summary

A leading medical devices manufacturer in Bacup is looking for a meticulous Quality Engineer to ensure high manufacturing standards in orthopedic components. The role includes risk management, process improvement, and mentoring the quality team. Candidates should hold a qualification in Quality or Mechanical Engineering with experience in regulated industries, proficient in QMS standards like ISO 9001. Join a supportive team dedicated to innovation in a balanced 35-hour workweek with early finishes on Fridays.

Benefits

Work with cutting-edge materials

Supportive team environment

Balanced working week

Qualifications

• Qualification in Quality or Mechanical Engineering (ONC / HNC / Degree) or equivalent.
• Experience in a Quality-focused role within medical or similar regulated industries.
• Strong working knowledge of QMS principles and standards (ISO 9001, ISO 13485, etc.).

Responsibilities

• Making risk-based decisions to drive product and process quality.
• Leading and supporting root cause analysis (RCA) and CAPA activities.
• Mentoring Quality Controllers and Inspectors, providing training and coaching.

Skills

Risk-based decision making

Root cause analysis

FMEA

Lean / Six Sigma tools

Process validation

Interpreting technical drawings

Internal auditing

Education

Qualification in Quality or Mechanical Engineering

Job description

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

• Making risk‑based decisions to drive product and process quality.
• Leading and supporting root cause analysis (RCA) and CAPA activities.
• Mentoring Quality Controllers and Inspectors, providing training and coaching.
• Leading process improvement, validation activities, and Lean initiatives.
• Designing and conducting MSA, Gauge R&R, sampling plans, and capability studies.
• Interpreting customer requirements and ensuring full compliance.
• Preparing clear and insightful quality metrics and reports for management.
• Developing PFMEAs, risk assessments, engineering change controls and documentation.
• Supporting New Product Introduction (NPI) projects.
• Liaising with customers and leading escalations when required.
• Conducting internal and supplier audits to ISO and customer standards.
• Ensuring promotion of quality and regulatory awareness across the company.

What You Need to Succeed

• Qualification in Quality or Mechanical Engineering (ONC / HNC / Degree) or equivalent.
• Experience in a Quality‑focused role within medical, automotive, or similar regulated industries.
• Strong working knowledge of QMS principles and standards (ISO 9001, ISO 13485, ISO 17025, ISO 14001, ISO 45001, FDA QSRs, MDD).
• Skilled in FMEA, root cause analysis, Lean / Six Sigma tools, and process flows.
• Competent in Process Validation, MSA, and Gauge R&R.
• Able to interpret complex technical drawings.
• Internal auditing experience to recognised standards.
• Methodical, conscientious, and an effective communicator.
• Excellent time‑management and the ability to multitask.
• Strong written communication and computer literacy.

What's in it for You?

• Work with cutting‑edge materials and technologies in the medical sector.
• Contribute to life‑changing products that support patient well‑being globally.
• Be part of a supportive, technically strong team with opportunities to grow.
• Enjoy a balanced 35‑hour working week with an early finish every Friday.