Senior Quality Assurance Specialist
4 days ago
This is a fantastic opportunity for a Senior Quality Engineer to join a leading Global Medical Device company based in the UK.
Main Responsibilities:- Support the compliance team to ensure all required certification is maintained.
- Complete internal audits in compliance with ISO 13485, 21 CFR, MDD/MDR, and UKCA regulations.
- Responsible for logging, investigating, and documenting non-conformities, ensuring appropriate action is taken to correct the issue and prevent recurrence.
- Prepare trending analysis data and escalate any trends to a Corrective and Preventative Action Report (CAPA).
- Assist with preparation for the Quality Review Meeting.
- Implement compliant processes and QMS documentation across multiple sites.
- Review and implement third-party agreements.
- Experience working in a Quality environment within the Medical Device Industry.
- Experience auditing to ISO 13485, preferably at Lead Auditor level.
- Experience generating and completing CAPA/Complaints and Root Cause Analysis.
- Experience/knowledge of auditing the MDR, 21 CFR, and UKCA regulations.
- Experience/knowledge of reporting incidents to competent authorities.
- Experience in writing processes compliant with standards.
- Experience of ISO 14001.
- Excellent interpersonal skills, including the ability to work as part of a team and with people from across the company.
- Good organisation and leadership skills and attention to detail.
- Good written and verbal communication skills.
- A can-do attitude with the ability to take initiative and work to deadlines across multiple simultaneous tasks and projects.
Austin Fraser is committed to being an equal opportunities employer and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.
Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.
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