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: kieran.martin@cypartners.co.uk