What are the responsibilities and job description for the Validation Manager position at Midwest Sterilization Corp.?
Validations Manager
Location: Jackson, MO
About Midwest Sterilization Corporation:
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!
