Provide integral support to the quality reliability team by ensuring finished products meet the established quality standards and world-wide regulatory requirements.
This position requires the ability to handle the completion of a diverse set of projects and tasks.
Job duties:Ensure conformance to quality systems with respect to internal procedures and applicable Quality Systems Regulations.Perform Bacterial Endotoxin sampling and testing.
Perform and support clean room monitoring and validation activities, including, but not limited to, microbial, particulate, and pressure differential testing.
Coordinate microbiological testing performed in-house and by outside laboratories to support routine and validation studies.
Support 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.
Perform complex mechanical, dimensional, and microbial assessments on raw materials or products/subassemblies and finished goods.
Provide guidance on sterilization control and sterile load release function.
Support Quality Reliability Engineering and Operations regarding validations and transfers projects.
Provide support with non-conformance investigations and correction implementation as required.
Perform documents updates as necessary.
Support Quality Reliability Engineering and Operations in the development and execution of internal test methods and validations.
Provide leadership and training to the QC, Production Operators and RI inspectors.Notify Quality Engineering in the event of a nonconformance or noncompliance situation.
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.
Perform additional duties as assigned.