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Quality Assurance Specialist
1 month ago
About STERIS
STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. We help our customers create a healthier and safer world by providing innovative healthcare, life sciences, and dental products and services.
Our Mission
We strive to be an equal opportunity employer and provide employment and advancement opportunities without regard to age, disability, gender reassignment, marriage or civil partnership, pregnancy and maternity, race, religion/belief, sex (gender), sexual orientation, or any other legally protected characteristic as defined by UK employment law.
Job Summary
We are seeking a Quality Assurance Specialist to join our team. The successful candidate will be responsible for ensuring compliance with regulatory requirements and industry standards. This will involve managing customer complaint investigations, facilitating CAPA and NCR investigations, and reviewing documentation.
Key Responsibilities
- Manage customer complaint investigations and complete complaint documentation.
- Facilitate CAPA and NCR investigations and may coordinate investigation documentation.
- Review documentation and support batch record release.
- Manage record retention practices within the site.
- Manage site calibration activities and recordkeeping.
- Support site inspection activities and recordkeeping.
- Coordinate internal and external audits.
- Support supplier quality and customer assessment activities.
- Track and trend site quality data.
- Support targeted Lean activities.
Requirements
- Two (2) years experience in a regulated industry (FDA/ISO).
- Customer complaint investigations.
- Audit coordination.
- CAPA and NCR investigations.
- Risk management.
- Supplier quality and customer assessments.
- Calibration.
About the Role
This is a challenging and rewarding role that requires strong analytical and problem-solving skills. The successful candidate will be able to work independently and as part of a team to ensure compliance with regulatory requirements and industry standards.
