Laboratory Quality Assurance Specialist
1 day ago
STERIS is a leading global provider of innovative healthcare and life sciences solutions, helping our Customers create a healthier and safer world. We are seeking a Laboratory Quality Assurance Specialist to join our team.
About the Role:The successful candidate will be responsible for administering quality functions at a site to ensure adherence to regulatory standards, including ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, and EU MDR. This role requires generating leading quality control initiatives with minimal supervision, including second sourcing, developing test methods, and troubleshooting lab and product issues.
- Assist in developing test methodologies and procedures
- Train laboratory technicians and specialists
- Work with quality assurance on internal and external audits and audit training
- Develop and validate methods
- Support and develop chemical testing procedures
- Support and develop technical requirements for raw material specifications based on input from potential vendors, product development staff, and process engineering
- Coordinate failure investigations by designing and performing lab-scale simulations of products made in the plant
- Troubleshoot and calibrate laboratory equipment
- Maintain and order laboratory supplies
Requirements:
- Bachelor's Degree in Science
- Minimum 6 years relevant laboratory experience in a regulated industry required
- Knowledge of standard quality tools such as FMEA, Root Cause Analysis, and Statistics
Estimated Salary Range: $120,000 - $180,000 per annum.
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