Department: Quality Assurance
Reporting: QA/RA Manager
The Quality Systems Compliance Specialist is responsible for implementing and promoting best in class quality assurance through the product lifecycle for Neurent Medical devices. The role requires a minimum of 3 years quality management systems experience in the medical device industry and the candidate must exhibit excellent problem solving and an innovative rational mindset to ensure implementation of advanced, efficient appropriate quality management practices. As a member of a growing team you must be flexible and willing to carrying out tasks outside of their routine responsibilities.
DUTIES & RESPONSIBILITIES
The role of Quality System Compliance Specialist includes but is not limited to the following responsibilities and skill sets:
- Coordinate the organisations feedback and complaint handling process.
- Support and coordinate improvement programs including conducting CAPA analysis to determine root cause and complete problem resolution
- Coordinate the internal audit program and ensure that Internal Audits are completed
- Support the preparation and conduct of External Audits
- Support compliance and continuous improvement QMS related projects within Neurent Medical.
- Support interactions with certification bodies in relation to QMS auditing, certification, and changes.
- Support processes for monitoring and measurement of processes including generation of routine QMS performance reports, objectives and KPIs.
- Conduct education and training with team members to ensure that best-in-class levels of compliance are maintained.
- Keep up to date on compliance best practices and constantly seek to improve compliance and efficiencies in line with best practices
- Degree in Quality Assurance, Quality Engineering or similar qualification,
- Minimum 5 years’ experience in a relevant role in the medical device industry,
- Broad experience of Medical Device Quality Management Systems,
- Experience in CAPA system management,
- Experience in Complaint handling systems,
- A working knowledge of FDA requirements and managing regulatory body audits,
- Proven ability of working in a cross-functional team environment,
- Knowledge and practical experience with the use of statistical techniques,
- Training and experience in auditing (internal auditing, supplier auditing or similar),
- Detail oriented with focus on implementing efficient systems for QMS Compliance.