Medical Device Precision Engineering – Orthopaedic Instruments & Implants
We are seeking an experienced and driven Quality Improvement Engineer to support ongoing operational excellence and compliance within our manufacturing environment. This role will focus on driving quality improvements, strengthening process capability, and ensuring alignment with regulatory and customer requirements, particularly within the medical device sector.
This is a hands-on, shop floor–focused role, working closely with production teams and overseeing the end-to-end machining process to ensure product quality is effectively managed, controlled, and continuously improved. The role also has a strong customer focus, supporting the resolution of customer issues and helping to build confidence through robust quality performance.
Key Responsibilities
- Maintain a strong shop floor presence, overseeing machining processes to ensure product quality is controlled at source
- Lead and support root cause investigations using structured problem-solving methodologies (e.g. 8D, DMAIC, 5 Whys)
- Drive continuous improvement activities to reduce defects, scrap, and rework
- Analyse manufacturing data to identify trends, variation, and improvement opportunities
- Support and develop process validation activities (IQ/OQ/PQ) where required
- Apply statistical techniques (SPC, Cp/Cpk, MSA, etc.) to improve process capability and control
- Ensure compliance with ISO 13485 and relevant regulatory requirements
- Support internal and external audit activities, including customer and regulatory audits
- Work cross-functionally with Production, Engineering, and Quality teams to implement sustainable improvements
- Develop and improve standard operating procedures (SOPs) and quality documentation
- Contribute to strengthening the Quality Management System (QMS)
- Deliver quality awareness sessions and training to site teams to improve understanding and promote a strong quality culture
- Support customer issue resolution and help improve overall customer satisfaction and OTIF performance
Skills & Experience Required
- Minimum 7+ years’ experience in a Quality / Manufacturing Engineering role
- Strong problem-solving capability, with a structured and data-driven approach
- Proven experience in data analysis and statistical methods (SPC, Minitab or equivalent)
- Solid understanding and practical application of ISO 13485
- Experience within the medical device industry (highly desirable)
- Strong regulatory awareness and understanding of compliance requirements
- Ability to lead and influence cross-functional teams
- Excellent communication and stakeholder management skills
Desirable Experience
- Experience in CNC machining / precision manufacturing
- Knowledge of validation processes and equipment qualification
- CMM experience and familiarity with geometric/variable measurement techniques
- Familiarity with aerospace or other regulated industries (beneficial)
Personal Attributes
- Proactive and results-driven
- Detail-oriented with a strong focus on quality and compliance
- Comfortable working in a hands-on, shop floor environment
- Able to operate effectively in a fast-paced, evolving environment
- Strong team player with the ability to challenge and influence constructively
Career Opportunity
- This role offers an excellent opportunity to gain deep exposure to the business, its processes, and customers. It provides a strong platform for future career development and progression within the organisation, opening up wider opportunities as the business continues to grow.
Summary
This is a key, hands-on and customer-focused role within the business, with a strong shop floor presence, providing the opportunity to make a significant impact on product quality, process control, regulatory compliance, and customer satisfaction, while supporting future growth and operational scale.
To apply: Email your CV and three reasons you are interested in working for us to: info@kirkstallprecision.co.uk