Description
Home based role for Leading Medical Device BodySalary: £50,000-£60,000
Location: Home Based
Main Purpose of Role
- Managing the medical device internal QMS
- Gaining and Maintaining all the global approvals and accreditation's needed to offer the required global medical device services
- Managing, changing and issue of documents and retention of records
- To write new and revised procedures and documents to address new requirements and non conformities found in the existing system
- To liaise with Global and UK technical management to ensure consistency with global and UK procedures and processes
- To plan and conduct professional management system audits in accordance with company procedures, enabling delivery of assessment and certification services that meet customer requirements and accreditation standards
Key Accountabilities
- Liaise with external approval and accreditation bodies and technical and accreditation staff to facilitate external audits and minimise non conformities
- To manage the GMDO Quality Co Coordinator team
- To work with the Global Medical Device certification Manager to understand developments in regulations and accreditation standards within medical device certification
- To oversee customer complaint and compliance query
- Provide technical support and staff training.
- Carry out internal audits of individual auditors, functions or offices to ensure internal compliance with relevant standards
- Conduct audits in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships
Skills & Knowledge
Essential
- Good working knowledge of quality management systems, standards, medical device compliance and auditing techniques
- Fluent written and spoken English
Desirable
- Detailed understanding of global medical device regulations
- Ability to motivate and coach others
- Knowledge of accreditation standard ISO 17021
- Ability to write clear procedures
Experience
Essential
- Significant work experience in positions with significant QA responsibility
- Significant medical device experience
- Significant auditing experience against recognised standards
If you are interested, or know anyone interested in this role, Please contact me on
Or add me on LinkedIn and Private Message me.
https://www.linkedin.com/profile/view?id=&trk=hp-identity-name