Salary: £75,000+

Location: West Yorkshire (Site-based)

Contract Type: Permanent

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

As a Head of Quality, you will be responsible for managing and implementing Quality functions across Quality Systems, Quality Engineering, Quality Assurance and Quality Control for manufacturing and design for a Medical Device Manufacturer.

Your responsibilities will include:

• Supporting the organisation in maintaining a working environment focused on and dedicated to Quality. As well as learning, respect, collaboration and teamwork.
• Management of and training and development of Quality department employees. Providing technical and process guidance to all personnel on site.
• Collaboration with other Senior Quality Assurance staff company wide and at other sites.
• Promote the company QMS to all employees, promoting requirements and compliance. As well as leading compliance management, and supplier quality management.
• Direct Quality Assurance, Quality Engineering and lab activities alongside cross-functional personnel across all business levels to support method/process validation, manufacturing and new product development.
• Provide design assurance leadership to support design/process functions, method/process validation, manufacturing and design transfers.
• Ensure shipped products meet specifications and are conformant to approved products including documentation such as DMR, BOM.
• Ensure raw materials and components are correctly inspected and released, and subsequently released to production. And that controlled environments are maintained to validated states.
• Oversee final product labelling and testing. And conformance to product specifications/DMR.
• Develop and maintain a Risk Management program consistent with Risk Management System.
• Participate in site project prioritisation, manufacturing planning, and NPD planning.
• Lead successful external audits of company Quality System.
• Plan and participate in Management reviews, including scheduling, conducting and reporting regarding Quality metrics.
• Identify and lead problem solving issues for Quality issues. Assisting operational groups and suppliers.

About you:

• Minimum educational background of BSc in a relevant Engineering or Scientific discipline is preferred.
• Extensive experience in Quality Engineering/Quality Assurance/Quality Control/Design Quality Assurance within the Medical Device Industry.
• Extensive experience as a Quality related Manager within the Medical Device Industry.
• Excellent working knowledge of QMS regulations such as ISO 13485 and 21CFR820. As well as GMP, risk management, cleanroom qualifications, process validation and more.
• Extensive experience within Quality processes, procedures, audits, measuring and testing for Medical Devices.
• Experience in hosting external Quality audits, as well as statistical process control and data analysis.
• High level of personal and professional integrity with a great worth ethic and the ability to work independently.
• Ability to function at a high level in a team setting whether leading or contributing.
• Comfortable in a fast paced setting where you will be responsible for contributing to directing.
• Exceptional organisational skills, attention to detail, verbal/written communication skills, and the ability to collaborate in a team setting.

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)