Role OverviewThis position is responsible for Sterility Assurance, including sterilization, environmental control, microbiological methods and processes, biocompatibility, and toxicology assessments and testing related to products designed and/or manufactured by OEM. The role requires a senior strategic leader and technical expert who can manage a broad set of activities.
What You Will Do
Provides expert technical opinion, advice, and recommendations to the President of OEM regarding Sterility Assurance, Microbiology, Biocompatibility, and Toxicology. Ensures compliant quality systems for Sterility Assurance, Microbiology, Biocompatibility, and Toxicology, meeting the applicable standards and OEM business needs.
Why It Might Be a Fit
Requires a senior strategic leader and technical expert with extensive knowledge and understanding of ISO 11135, 11137, 11138,14644 and 10993 requirements, and expertise in achieving compliance. Proven audit experience for various regulatory bodies/agencies is a must.
Requirements
- Minimum education bachelor’s degree in a technical field, advanced degree preferred.
- Minimum 15 years’ experience in a sterilization-related field, the medical device industry in RAQA / Engineering / Manufacturing/environment, with 5 years of managerial experience.
- Extensive knowledge and understanding of ISO 11135, 11137, 11138,14644 and 10993 requirements along with expertise in achieving compliance.
- Proven audit experience for various regulatory bodies/agencies.
- Experience in a matrix management organization is a must.
- Excellent Communication skills with the ability to articulate technical information in a clear and concise manner.
- Practical experience with aspectic sampling, EO, gamma/ E.Beam Sterilization methods essential, steam, filtration sterilization, and aseptic fill processes desirable.
Benefits
- Medical, prescription drug, dental and vision insurance
- Flexible spending accounts
- 401(k) savings plan
- PTO
- Short- and long-term disability
- Parental leave
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