What are the responsibilities and job description for the Regulatory Compliance Officer position at Midwest Sterilization Corp.?
Responsibilities and Qualifications
The Validations Manager will be responsible for leading and mentoring the Validation Technical Support Team, ensuring compliance with company and industry standards.
This includes reviewing and approving sterility assurance validation protocols, including Process Performance Qualification (PQ), Microbiological Performance Qualification (MPQ), Routine cycle requalifications.
The manager will also oversee validation processing for medical device manufacturers, including process cycle development, equipment setup, and direct collaboration with customers.
In addition, the manager will conduct quality trend analysis and validation performance reporting at least annually.
- Be part of an industry leader in sterility assurance and medical device validation.
- Work with cutting-edge technology in a highly regulated, safety-critical industry.
- Collaborate with top-tier medical device manufacturers and make a real impact in healthcare.
