What are the responsibilities and job description for the Associate Quality Systems Manager position at beBee Careers?
About the Role
We are seeking a skilled professional to join our Quality team as an Associate Quality Systems Specialist. In this role, you will review and audit Device History Files (DHF) and technical documentation to ensure compliance with regulatory requirements.
Your key responsibilities will include:
- Ensuring documentation submitted to Quality complies with regulatory requirements and internal policies
- Reviewing and auditing DHF and technical documentation, including stability protocols/reports, validation/verification protocols and summaries, risk management documents, post-market surveillance and performance evaluation reports, product specifications, scientific, analytical, and clinical summaries, safety and performance requirement reports
- Assessing and validating good documentation and record-keeping practices
The successful candidate will have a strong attention to detail, be a fast learner, and comfortable asking questions.
