Quality & Validation Engineer

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.

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Inspection department at Kirkstall Precision

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