The Quality Assurance Manager is responsible for the management of the ISO 13485 aspects of the Quality Management System and for ensuring compliance with all related policies and procedures as well as ensuring full integration of the QMS into operations.
Will liaise with appropriate regulatory bodies to maintain system certification and product registrations and will support the design and development team in new product
introduction and the achievement of highest standards of product and service quality.
- To ensure that the Oval Quality Management System complies with all aspects of ISO 13485.
- Ensure that all technical files and design history files comply with US, UK and EU regulatory requirements, in particular the Medical Device Regulation (EU) 2017/745 and UKCA requirements.
- Coordinate and direct the implementation of new standards into practice.
- To author new Quality Management System policies, procedures and documentation as required.
- Perform and participate in internal, external and third part audits as necessary.
- Work closely with project teams to ensure that Oval’s devices meet regulatory and customer requirements.
- Liaise with external regulatory bodies for both audits/inspections and for product regulatory submissions.
- Train employees on company policies, systems, tools and techniques.
- Investigate specification failures, determine root cause and work with cross function teams to implement corrective actions.
- Instill culture of continuous improvement.
- Develop and approve company suppliers.
Experience/Skills needed to fulfil the role
- A minimum of 5 years’ experience in the Medical Device or Pharmaceutical Industry.
- Experience of operating to ISO 13485.
- Strong knowledge of manufacturing processes for device components.
- Good influencing skills; persuasive without being dictatorial.
- Good decision-making ability.
- Sound knowledge of statistics and data analysis.
- Excellent oral and written communication skills.
- Good team player.
- Personable and high level of integrity.
- Understanding of pharmaceutical cGMPs.
- Experience with drug device combinations.
- Experience in Lean manufacturing tools and techniques.
- Degree in engineering or life sciences