Quality Management Systems Specialist
4 days ago
We are seeking a highly skilled Quality Management Systems Specialist to join our team at the Rayner Surgical Group.
About the RoleThis is a challenging and rewarding position that requires a strong background in quality management systems, with experience in implementing and maintaining effective QMS solutions.
The successful candidate will work closely with our Senior QMS Manager to ensure that our quality management system is fit for purpose and suitable for all divisions of the company.
This role involves undertaking maintenance, administration, and development of the Internal Audit System, as well as training the Internal Audit Team.
You will also assist in the maintenance and administration of External Audits, undertake maintenance, administration, and development of the QMS elements of the onboarding and offboarding System, and assist in the maintenance, administration, and development of the e-QMS (Q-Pulse) platform.
In addition, you will assist in the maintenance, administration, and execution of the Change Control System and Planned Deviation System, undertake process development to streamline and simplify Quality Management and associated systems, and assist in the identification, management, and completion of Corrective and Preventive Actions.
This includes archiving company material, ensuring an efficient system which is easily accessed and utilised in line with the relevant procedures.
You will work closely with the QMS Manager in establishing and maintaining standard operating procedures for document development, management, and control.
This includes documents associated with Quality Systems, such as the Quality Manual, Corporate and facility requirements, manufacturing and quality specifications, Device Master Records, and documentation related to Quality System training.
As part of this role, you will support other teams in the creation and maintenance of Quality Management or equivalent System related procedures, records, and work instructions, as required.
Key Responsibilities- Maintenance, administration, and development of the Internal Audit System
- Assistance in the maintenance and administration of External Audits
- Maintenance, administration, and development of the QMS elements of the onboarding and offboarding System
- Assistance in the maintenance, administration, and development of the e-QMS (Q-Pulse) platform
- Assistance in the maintenance, administration, and execution of the Change Control System and Planned Deviation System
- Process development to streamline and simplify Quality Management and associated systems
- Assistance in the identification, management, and completion of Corrective and Preventive Actions
- Archiving company material, ensuring an efficient system which is easily accessed and utilised in line with the relevant procedures
- Experience working with Quality Management Systems
- Computer literate, working knowledge of Microsoft office products e.g., Excel, Word, etc.
- Experience working in Quality Assurance or Regulatory Affairs
- Experience of working with electronic QMS e.g., Ideagen 'Q-Pulse Platform'
- Experience in Auditing (External and Internal)
- Knowledge of ISO 13485
- Knowledge of CFR820
- Advanced Excel, Word, and Adobe skills
- A competitive salary range: £45,000 - £60,000 per annum
- A comprehensive benefits package including private healthcare, wellbeing allowance, and on-site restaurant
- A collaborative and dynamic work environment
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