Midwest Sterilization Corporation is a leader in sterility assurance and medical device validation, ensuring the highest standards of safety and compliance in the healthcare industry. We are looking for a Validations Manager to lead our validation technical support team and oversee sterility assurance validation processes for medical device manufacturers. This is a great opportunity for a detail-oriented professional with a strong background in validation, quality assurance, and regulatory compliance.
Key Responsibilities:
Lead and mentor the Validation Technical Support Team, ensuring compliance with company and industry standards.
Review and approve sterility assurance validation protocols, including: Process Performance Qualification (PQ), Microbiological Performance Qualification (MPQ), Routine cycle requalifications
Oversee validation processing for medical device manufacturers, including process cycle development, equipment setup, and direct collaboration with customers.
Assign and manage validation activities within the team, ensuring timely and efficient execution.
Conduct quality trend analysis and validation performance reporting at least annually.
Qualifications & Experience:
Bachelor's degree (STEM-related field preferred).
3+ years of experience in validation, quality assurance, engineering, or a related field.
Expertise in ISO 11135 (EO Sterilization of Healthcare Products), ISO 13485 (International Quality Systems), and CFR 820 (FDA Quality System Regulations).
Strong problem-solving and leadership skills with a detail-oriented mindset.
Why Join Midwest Sterilization Corporation?
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.
Grow your career in a company that values quality, compliance, and continuous improvement.
Apply today and take the next step in your career with Midwest Sterilization Corporation!