Medical Device Precision Engineering – Orthopaedic Instruments & Implants
We are looking for an experienced Quality & Validation Engineer to join our fast-growing precision engineering business specialising in orthopaedic instruments and implants. You will play a central role in ensuring that products, processes, and equipment consistently meet the highest standards of quality, safety, and regulatory compliance.
This position suits a technically capable engineer with excellent attention to detail, and someone motivated to drive improvements across both quality and validation disciplines within a dynamic and growing medical device organisation.
Key Responsibilities
Validation
- Develop, execute, and document IQ/OQ/PQ protocols and reports in accordance with regulatory, customer, and internal quality requirements.
- Plan, schedule, and perform validation activities across equipment, processes, test methods, and software systems.
- Creation of User Requirement Specifications (URS) and validation protocols and reports.
- Apply appropriate statistical tools (e.g., Minitab) to analyse data and support validation conclusions.
- Support the introduction and qualification of new equipment, tooling, fixtures, quality inspection and manufacturing processes.
Quality Engineer
- Support and maintain the Quality Management System (QMS) in accordance with ISO 13485, including document control, change control, and continuous improvement of quality processes.
- Lead and support nonconformance (NCR) investigations, ensuring accurate documentation, timely resolution, and effective corrective actions.
- Conduct root cause analysis and drive implementation of CAPA to prevent recurrence of quality issues.
- Participate in internal audits, supplier audits, and external regulatory audits, preparing documentation and providing technical justification where required.
- Support incoming inspection, in-process quality checks, and final product release activities when needed.
- Perform gauge R&R studies, measurement system analysis (MSA), and ensure continued suitability of inspection methods.
- Assist in supplier quality activities, including qualification, performance monitoring, and investigation of supplier-related nonconformities.
- Support creation and review of quality plans, control plans, first article inspection (FAI) documentation, and product verification plans.
- Monitor and report quality metrics (e.g., scrap, yield, NCR trends) and contribute to data-driven improvement initiatives.
Risk Management
- Conduct and support FMEA and risk assessments across products, processes, and equipment.
- Ensure risk control measures are implemented, verified, and maintained in line with regulatory expectations.
- Support ongoing product and process risk reviews throughout the lifecycle.
Cross-Functional Collaboration
- Work closely with Senior Management, Production Engineers, Operations, and Finishing teams to ensure alignment on quality and validation requirements.
- Provide technical guidance on quality best practices, validation planning, and regulatory expectations.
- Troubleshoot quality or process issues, supporting teams with problem-solving and robust engineering solutions.
Skills & Experience Required
- Minimum 3 years’ experience in validation or quality engineering within medical devices, implants, precision engineering, or other regulated industries.
- Strong working knowledge of ISO 13485, QMS principles, and regulatory requirements for medical devices (MDD/MDR/FDA).
- Experience with validation documentation including URS, FAT/SAT, equipment qualification, and software validation.
- Competent with statistical tools, data analysis, and problem-solving methodologies.
- Skilled in FMEA, risk management, root cause analysis, and quality engineering tools (5 Whys, Fishbone, 8D, DMAIC).
- Experience supporting internal audits, CAPA investigations, NCR management, or supplier quality activities.
- Degree-qualified in Engineering, Science, or relevant discipline (or equivalent).
- Excellent organisational skills with the ability to work under pressure and manage multiple priorities.
- Strong communication and interpersonal skills with the ability to work effectively cross-functionally.
- Proactive, flexible, and comfortable operating within a rapidly evolving and growing business.
What We Offer
- A key role in a rapidly expanding, innovative medical device precision engineering environment.
- Opportunities for professional development and progression into senior engineering or specialist quality roles.
- A collaborative culture that values teamwork, technical excellence, accountability, and continuous improvement.
- The opportunity to make a meaningful impact on high-precision medical devices that improve patient outcomes worldwide.
Employment Type
Permanent or 12M FTC
To apply: Email your CV and three reasons you are interested in working for us to: info@kirkstallprecision.co.uk
