Senior Sterility Manager

🕒 4 days ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $152k - $229k / year

⏰ Full Time

🟠 Senior

👔 Manager

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Teleflex

WebsiteLinkedInAll Job Openings

10,000+ employees

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 $275k Venture Round on 2010-01

Healthcare Insurance • Medical Devices • Pharmaceuticals

Teleflex is a global provider of innovative medical devices and solutions, dedicated to supporting healthcare professionals and enhancing patient care. With a diverse portfolio that includes products for anesthesia, emergency medicine, interventional cardiology, and more, Teleflex aims to improve the health and quality of lives. The company emphasizes its commitment to education and customer support in the healthcare sector.

📋 Description

• 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.

🎯 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 • participation in 401(k) savings plan • various paid time off benefits, such as PTO, short- and long-term disability and parental leave