Quality Engineer

• Play a pivotal role in strengthening QMS
• Be hands on in regulatory excellence in a highly visible role.

About Our Client

This organisation is a wellestablished medical device manufacturer with a strong reputation for quality, compliance and operational excellence. They offer a collaborative, fastpaced environment where quality professionals are empowered to make a real impact on both products and patients.

Job Description

• Support production quality activities including inprocess inspection, final release and lot history record review.
• Lead Material Review Board (MRB) activities and drive disposition of nonconforming materials.
• Ensure timely product release to meet customer delivery commitments.
• Act as a quality interface with customers and suppliers to resolve quality issues.
• Monitor supplier performance, manage corrective actions and support PPAP and supplier qualification activities.
• Investigate customer complaints and returned products, ensuring thorough root cause analysis.
• Support compliance with ISO 13485 and FDA 21 CFR Part 820 requirements and maintain audit readiness.
• Lead and support internal audits, CAPAs and continuous improvement initiatives.
• Provide quality oversight for product, process and facility transfers, including equipment moves and revalidation.
• Partner crossfunctionally with Operations, Engineering and Validation teams on change control and risk management.
• Analyse quality metrics, drive trend reporting and support SPC and datadriven decisionmaking.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.


The Successful Applicant

• Bachelor's degree in Engineering, Life Sciences or a related technical discipline (or equivalent experience).
• 5+ years' experience in medical device manufacturing within a quality role.
• Strong working knowledge of ISO 13485, FDA 21 CFR Part 820 and ISO 14971.
• Proven experience leading CAPAs, investigations and audit readiness activities.
• Experience supporting facility transfers, line moves or site transitions is highly desirable.
• Confidence working in fastpaced production environments with a handson approach.
• Experience with SPC, MSA and statistical tools (Minitab preferred).
• ASQ certification (CQE, CQA or CQM) advantageous but not essential.

What's on Offer

• Opportunity to take ownership of quality during highimpact facility and process transfer projects.
• Strong visibility across operations, engineering and leadership teams.
• Handson role with real influence on production output and compliance.
• Stable, wellestablished manufacturing environment with longterm career potential.
• Chance to further develop regulatory, audit and operational quality expertise within medical devices.

Contact

Bridget Petti

Quote job ref

JN-062026-7029795