About the role
We are looking for a Quality Associate to support the Quality team and wider business with administrative tasks including training, supplier management and documentation control. The successful applicant will take the lead in ensuring key Quality System processes are documented, monitored and maintained in line with business requirements.
What you will be doing?
- Supporting the implementation, monitoring and development of quality assurance processes and procedures.
- Assisting in managing the review, revision and distribution of QMS documentation.
- Providing internal audit support.
- Undertaking quality monitoring activities.
- Assisting with instrument calibration activities, risk assessments and supplier quality management.
- Responsible for all company’s document archiving activities.
What we are looking for?
- A minimum of two years’ experience in the Medical Device or Pharmaceutical Industry
- Good understanding of sterile manufacture of finished products
- Clear understanding of GMP, ISO13485 and other applicable standards e.g., ICH, PICS, Eudralex volume 4
- Auditing skills experience
- Confident understanding and working with controlled and regulatory documents
- Understanding of how to work to the requirements of industry standards and regulations
- Experience working with MS Office packages, Word and Excel creating SOP’s and work instructions
- History of working with a document management system
- 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
- Excellent presentation skills for delivery of Quality Metrics
- Skilled in using the management chain effectively
- Outstanding verbal and written communication skills
- Good decision-making ability
- Excellent attention to detail and adherence to procedures
- Proactive approach to managing tasks and seeking opportunities to improve documents and processes
- Comfortable working within small, open teams
How do I apply?
If you are interested, please send a CV and covering letter to firstname.lastname@example.org with the subject line “Quality Associate FTC”.