Salary: £45,000 - £55,000

Location: West Yorkshire (Site-based)

Contract Type: Permanent

Are you looking to develop in your career within Quality Engineering in the Medical Device space? An exciting and unique opportunity to join a fantastic company based in West Yorkshire is now available!

As a Senior Quality Engineer, you will be responsible for leading manufacturing and process development activities associated with manufacturing. As well as contribution to product life cycle and the development of new and existing processes.

Your responsibilities will include:

• Analysis of manufacturing KPIs and development of continuous improvement projects.
• Partner with manufacturing, quality and R&D Engineers across company sites to develop and validate processes.
• Root Cause Analysis to identify opportunities to optimise and improve manufacturing processes including continuous improvement engineering methods such as SIX Sigma and LEAN.
• Develop tooling, assembly jigs and fixtures, employing technical design skills in support of operations. Including test method validation and cost/yield considerations.
• Equipment management via validation (IQ, OQ and PQ) and managing maintenance and calibration.
• Develop training and Quality Documentation for production processes. As well as technical support for documentation with company QMS such as design transfer and qualifications, regulatory submissions, equipment management and process/product development.
• Support analysis and resolution of manufacturing and compliance issues such as CAPAs and non-conformances.
• Technical support for design transfer and production of medical devices as well as commercial activities, ensuring R&D processes are scaled up and characterised via new technology and standard work.
• Lead manufacturing support tasks, giving guidance to engineers and technicians on work, training engineers and technicians and coordinate engineer/technician work where appropriate.
• Lead and establish project plans ensuring products/work is completed to customer expectations using project management tools.
• Drive the development of experiments and tests to qualify and validate manufacturing processes, analyse results and issue reports.
• Support internal Quality audits where required.
• Compliance with company HSE policies and procedures.

About you:

• Minimum educational background of BSc in a relevant Engineering or Scientific discipline is preferred.
• Working knowledge of equipment qualification and design/process verification within the medical device industry. As well as Medical Device manufacturing experience.
• High level of personal and professional integrity with a great worth ethic and the ability to work independently.
• Comfortable in a fast-paced setting.
• Exceptional organisational skills, attention to detail, verbal/written communication skills, and the ability to collaborate in a team setting.
• Ability to work across time zones and travel if required.
• Effective documentation skills as well as excellent problem-solving skills.

If this opportunity interests you, or you want to learn more about the role, please get in touch with or email your CV to: (url removed)