Senior Quality Assurance Specialist
4 weeks ago
**As a key member of the quality team, the role of the Senior QA Specialist is to maintain and manage QMS elements such as CAPA, Risk Assessment and the company programmes for audits.**
- Manage the audit programme with internal departments, suppliers, customers, regulatory authorities, notified bodies.
- Coordinate investigations relating to audit nonconformities
- Coordinate risk assessment (process and product)
- Assist with investigating customer complaints, nonconformities and opportunities for improvement.
- Identify Root Cause/s of nonconformances / customer complaints
- Collate data for trending and analysis to support communication meetings with management / quality teams.
- **Qualification equivalent to a Degree in a scientific discipline OR 5+ years’ experience in a Quality/ QMS/ QA / Auditing role (ideally within manufacturing / quality in the medical devices or Pharmaceutical industry).**:
- A working knowledge of QMS principles ideally GMP procedures/ ISO 13485
- Great organizational skills and ability to work to deadlines.
- Ability to work as part of a team and also demonstrate leadership qualities.
- Excellent communication skills across all business stakeholders (both internal and external).
- Driving license and own transport (Own transport desired as the role may take you to either of the 2 sites within the Stoke on Trent area)
Hours of work: Monday - Friday, between 8am and 4pm or 9am and 5pm (35 hours)
Holidays: 25 days + bank holidays / Onsite parking
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