Head of Quality
£80,000 - £90,000
Medical Devices
Yorkshire
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 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.
Benefits Package in place for discussion.
To discuss this role further please contact Matthew Moulton at Aurora Lifesciences.
#J-18808-Ljbffr
£80,000 - £90,000
Medical Devices
Yorkshire
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 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.
Benefits Package in place for discussion.
To discuss this role further please contact Matthew Moulton at Aurora Lifesciences.
#J-18808-Ljbffr
