Head Of Quality Assurance

Aurora Lifesciences has been exclusively retained with a cutting edge medical devices organisation based in Leeds for a Head of Quality Assurance. Only Medical Device Quality Leaders will be considered for this post. The Head of Quality Assurance will have demonstrated experience working to ISO13485 and will have a strong engineering background.

The Role

Head of Quality is a leader and key member of a dynamic management team who is responsible for directing and managing the implementation of the business strategy regarding Quality Systems, Quality Assurance, Quality Engineering and Quality Control for both manufacturing and design activities.

Job Responsibilities

• Collaborates with Quality Assurance Directors at other facilities to assure alignment of quality processes across sites.
• Manages the Quality department personnel and supplies technical and process guidance to other personnel at the site.
• Directs Quality Assurance/Quality Engineering/Microbiology/Chemistry lab activities in collaboration with cross-functional personnel at all levels to support process characterization, methods validations, process validations, manufacturing, and new product development.
• Provides design assurance leadership to support design qualifications, process characterization, methods validations, design verification and validations, process validations, design transfers and sustaining manufacturing.
• Oversees the final product labeling, testing, and disposition processes to ensure conformity with the DMR and product specifications.
• Develops and maintains a Risk Management program consistent with the risk management system.

Experience

• Strong working knowledge of Quality Management System regulations (21CFR820 and EN ISO13485) and of recognized international standards and expectations related to current Good Manufacturing Practice, risk management principles, cleanroom qualification; biocontamination control; packaging processes; sterilization processes; and process validation.
• Strong working knowledge of quality processes, procedures, auditing, measuring, and testing for medical devices.
• Experience with statistical process control and statistical data analyses.
• Experience hosting external quality system audits.

Working as a key leader on site you can expect plenty of variety and challenges in your role and the chance to tackle a range of complex quality improvement projects whilst working towards the development & growth of the product that will be sold around the world.

Benefits Package To Be Discussed

Please contact Matthew Moulton at Aurora Lifesciences to find out more about this fantastic role.