Sr Engineer, Quality Sterilization – CR

Develop and implement effective sterilization procedures, lead sterilization validation activities, and provide compliance with regulations and leadership to ensure sterility maintenance. Collaborate with cross-functional teams, troubleshoot sterilization issues, and collaborate with environmental control to support the manufacture and development of medical device processes. Collaborate with the reliability department on quality, packaging, labeling, sterilization, pyrogen, and shelf-life related issues. Support manufacturing process changes, product design improvements, and the implementation of new products or processes.Job Duties:

1. Identifies sterilization requirements to meet regulations.
2. Establish sterilization strategies.
3. Develops and implements sterilization procedures.
4. Lead and conduct cycle development activities for sterilization and conducts such validations for new processes.
   1. Generate project plans, validation master plans, test protocols, and reports for sterilization validation.
   2. Identify budgets for sterilization validation activities.
   3. Determine loading configurations. Determine sterilization cycle parameters based on fractional cycle approach. Identify appropriate PCD configurations, resistance hierarchy, and required quantity for validation.
   4. Coordinate microbiological testing performed in-house and by outside laboratories, to support validation studies.
5. Lead and conduct revalidation activities and studies for Ethylene Oxide, radiation and steam sterilization processes. Work closely with Operations and Quality Engineering teams to coordinate with vendors and execute revalidation activities.
6. Conduct technical justifications and physical studies for adoption of new products into existing sterilization cycles, including, but not limited to, sterilization validation, endotoxin level testing (LAL), product bioburden testing, and residual testing.
7. Provide sterilization expertise during interface with cross-functional teams as well as regulatory agencies, including FDA and ISO notified bodies.
8. Troubleshooting sterilization issues: Provide sterilization expertise and write-ups to support NCRs and/or CAPAs
9. As required, support clean room monitoring and validation activities, including, but not limited to, microbial, particulate, and pressure differential testing.
10. As required, support packaging and labelling activities to improve the packaging process.
11. Works with Engineers to review process changes and resolve product quality issues.
12. Obtain, analyze, and present to management the key performance indicators related to quality process.
13. As assigned, maintains various Quality Systems such as CAPA, complaints, Non-conformance, supplier quality, equipment calibration, internal auditing, and quality metrics data analysis.
14. Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
15. Perform additional duties, as assigned