We require a QA Officer to join a leading medical device company at their site based in Cambridge. The QA Officer will support the Quality team and wider business with administrative tasks including training, supplier management and documentation control. The QA Officer will take the lead in ensuring key Quality System processes are documented, monitored and maintained in line with business requirements.
- To manage all training related issues including employee induction, ongoing training and external training courses.
- To ensure training records for all employees are complete (in both the employee’s files and on the server) and to maintain those records going forward.
- Support the implementation, monitoring and development of quality assurance processes and procedures.
- Assist in managing the review, revision and distribution of QMS documentation ensuring effective document control.
- Provide internal audit support.
- Undertake quality monitoring activities.
- Manage and assist with instrument calibration activities. Ensure that calibration documents are constantly and properly updated to make available up to date records of activities for future referencing. Inspect conditions of calibrated measurement and specifications.
- Assist with safety risk assessments.
- Assist with supplier quality management.
- Be responsible person for all company’s document archiving activities.
- Confident understanding and working with controlled and regulatory documents
- Flexible working with different departments to understand their responsibilities and needs
- Comfortable with attention to detail and adherence to procedures
- Proactive approach to managing tasks and seeking opportunities to improve documents and processes
- Understanding of how to work to the requirements of industry standards and regulations
- Good experience working with MS Office packages, Word and Excel creating SOP’s and work instructions
- History of working with a document management system
- Must be comfortable working within small, open teams
- Previous experience working within a Quality or technical team/department for a medical device or pharmaceutical company
- Experience working within an ISO 9001/13485 environment or similar
- Experience/knowledge of cGMP activities
- EU GCP, GLP, MDR/D or CFR (FDA) exposure would be beneficial
- Engineering and scientific background preferred
- A degree in engineering/science-based qualification an advantage
Competitive salary in line with experience
Job Ref: 6092