Quality Engineer – Medical Equipment
Location: Sheffield
Salary: Up to £46,000 + Bonus + Excellent Benefits
Job Type: Permanent | Full-Time
An exciting opportunity has arisen for an experienced Quality Engineer to join a leading medical equipment manufacturer based in Sheffield. This role is pivotal in ensuring product quality, supporting regulatory compliance, and driving continuous improvement within a highly regulated industry.
The successful candidate will collaborate with internal teams, suppliers, and customers to maintain the highest standards of quality and compliance in line with ISO and QSR requirements.
Key Responsibilities
* Deliver and document training on work instructions, policies, and procedures to ensure team members are fully competent before working independently.
* Use quality tools to implement process improvements, including process flowcharting, Pareto analysis, SPC, DOE, and gauge R&R.
* Act as the primary customer liaison for quality issues and manage complaints efficiently.
* Collect, analyse, and present data using statistical methodologies to support product and process improvements.
* Support the development of QMS deliverables and APQP activities, including risk analysis, FMEA, CAPA, and validation plans.
* Conduct process capability studies to determine machine and process performance.
* Develop inspection criteria connecting customer requirements to manufacturing processes, including sampling plans and gauging methods.
* Support continuous improvement and productivity initiatives.
* Perform internal audits, quality reviews, and prepare reports for compliance and performance monitoring.
* Review engineering drawings for correct application of GD&T, material specifications, and key inspection characteristics.
* Recommend improvements to processes, products, and quality standards.
* Work closely with cross-functional teams to resolve production and quality challenges.
* Ensure strict adherence to the Quality Management System (QMS) and regulatory standards.
Experience & Requirements
* Degree in Engineering OR Science discipline OR recognised engineering apprenticeship.
* Experience in a highly regulated industry, ideally medical equipment (Aerospace or Automotive also considered).
* Strong knowledge of manufacturing processes – ideally casting or forging experience.
* Familiarity with ISO, QSR, and FDA regulatory requirements.
* Experienced in PPAP, GD&T, validation processes, and statistical quality tools.
Package & Benefits
* Salary: Up to £46,000 / Year
* Bonus: 7.5% annual discretionary bonus
* Holidays: 33 days including bank holidays + Summer and Christmas shutdowns
* Pension: 7% employer contribution (minimum 4% employee) after 3 months
Hours: 37.5 hours per week
* Mon–Thu: 07:00–16:00
* Fri: 07:30–12:00