Senior Sterility Manager

🕒 vor 6 Tagen

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $152.000 - $229.000 / Jahr

⏰ Vollzeit

🟠 Senior

👔 Manager

🦅 H1B-Visum-Sponsor

Dieses Unternehmen hat in der Vergangenheit H1B-Visa gesponsert.

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Teleflex

WebsiteLinkedInAlle Stellen

10.000+ Mitarbeiter

⚕️ Krankenversicherung

💊 Pharmazie

💰 €275.000 Venture Round im 2010-01

Healthcare Insurance • Medical Devices • Pharmaceuticals

Teleflex ist ein globaler Anbieter von innovativen Medizinprodukten und -lösungen, der sich der Unterstützung von Gesundheitsfachkräften und der Verbesserung der Patientenversorgung widmet. Mit einem vielfältigen Portfolio, das Produkte für Anästhesie, Notfallmedizin, interventionelle Kardiologie und mehr umfasst, zielt Teleflex darauf ab, die Gesundheit und Lebensqualität zu verbessern. Das Unternehmen betont sein Engagement für Bildung und Kundensupport im Gesundheitswesen.

Beschreibung

• Provides expert technical opinion, advice, and recommendations to the President of OEM regarding Sterility Assurance, Microbiology, Biocompatibility, and Toxicology. • Responsible for ensuring compliant quality systems for Sterility Assurance, Microbiology, Biocompatibility, and Toxicology, meeting the applicable standards and OEM business needs • Responsible for ensuring all technical aspects for establishing, validating, maintaining, and dispositioning sterilization processes - EO (cycle development, residuals, parametric release) and Gamma & E-beam (dose setting, auditing, dose mapping) are delivered per the applicable standards for products at the applicable facilities. • Ensure sterilization failures are investigated and implement robust CAPAs. • Leading all technical aspects of establishing, validating, maintaining, and dispositioning cleanroom environment to meet ISO14644 standards (Bioburden testing, Environmental monitoring (EM), OOS/OOT, etc) • Sets technical direction for SA strategy development in collaboration with business partners. • Oversee toxicological risk assessments, including: • Lead the biocompatibility program with applicable standards, including: • Manages and supports Quality Improvement projects in Sterility Assurance. Constantly delivers improved value for all stakeholders by driving and developing a culture of excellence through continuous improvement. • Supports Sterilization Supplier Quality Management and partnership with the Operations Procurement team.

🎯 Anforderungen

• 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.

🏖️ Vorteile

• medical, prescription drug, dental and vision insurance • flexible spending accounts • participation in 401(k) savings plan • various paid time off benefits, such as PTO, short- and long-term disability and parental leave