Quality Assurance Specialist
4 weeks ago
At STERIS, we strive to create a healthier and safer world by providing innovative healthcare and life science solutions.
Key Responsibilities
- Manage document control transactions to ensure compliance with regulatory requirements.
- Investigate customer complaints and maintain accurate documentation.
- Facilitate CAPA and NCR investigations, coordinating investigation documentation as needed.
- Review DHRs and support batch record release to ensure quality and safety.
- Implement and maintain record retention practices within the site.
- Manage site calibration activities and maintain accurate records.
- Support site inspection activities and recordkeeping to ensure compliance.
- Coordinate internal and external audits to ensure quality and regulatory compliance.
- Support supplier quality and customer assessment activities to ensure quality and safety.
- Track and trend site quality data to identify areas for improvement.
- Support targeted Lean activities to improve efficiency and quality.
Required Experience
- Two years of experience in a regulated industry (FDA/ISO 13485).
- Proven experience in customer complaint investigations.
- Audit coordination experience.
- CAPA and NCR investigations experience.
- Risk management experience.
- Supplier quality and customer assessment experience.
- Calibration experience.
Equal Opportunities
STERIS plc is an equal opportunities employer, providing 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.
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