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Bishop's Stortford, Hertfordshire, United Kingdom STERIS Full timeAbout the RoleWe are seeking a highly motivated and detail-oriented Quality Specialist to join our team at STERIS. As a Quality Specialist, you will play a critical role in ensuring the quality and compliance of our products and services.Key ResponsibilitiesCoordinate document control transactions and site record retention.Manage customer complaint...
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Quality Assurance Specialist
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Bishop's Stortford, Hertfordshire, United Kingdom STERIS Full timeAbout the RoleWe are seeking a highly motivated and detail-oriented Quality Specialist to join our team at STERIS. As a Quality Specialist, you will play a critical role in ensuring the quality and compliance of our products and services.Key ResponsibilitiesCoordinate document control transactions and site record retention.Manage customer complaint...
Quality Assurance Specialist
2 months ago
We are seeking a highly skilled Quality Specialist to join our team at STERIS. As a Quality Specialist, you will play a critical role in ensuring the quality of our products and services meets the highest standards.
Key Responsibilities- Assist in the administration of quality functions at a site to ensure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards.
- Coordinate document control transactions, site record retention, calibration and inspection activities.
- Manage customer complaint investigations and complete complaint documentation.
- Facilitate CAPA and NCR investigations and may coordinate investigation documentation.
- Review DHR's 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.
- 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.
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.
We are committed to being an equal opportunities employer and welcome applications from diverse candidates.
