Senior Quality Engineer – Sterility Assurance & Validation

🔥 0 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $115.5k - $140k / year

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Teleflex

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

🏭 Manufacturing

⚕️ Healthcare Insurance

💰 $275k Venture Round on 2010-01

Healthcare • Manufacturing • Healthcare Insurance

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

• Serve as the internal technical owner for the Sterility Assurance program • Provide technical oversight of ethylene oxide (EO) and radiation sterilization processes • Support sterilization cycle transfer, validation, requalification, and maintenance of the validated state • Review and approve sterilization qualification and requalification protocols and reports • Review sterilization cycle deviations, excursions, nonconformances, and change assessments • Support investigation, root cause analysis, CAPA, and risk assessment for sterilization-related issues • Coordinate and review annual Sterility Assurance and bioburden technical assessments • Provide oversight of radiation dose audits, including review of Quarterly Dose Audit results, as applicable • Monitor bioburden data and trends and coordinate specialized microbiology support when required • Provide technical oversight of contract sterilizers and support supplier qualification, audits, SCARs, and quality agreements • Maintain sterilization procedures, technical documentation, validation records, and required periodic reviews • Support regulatory inspections, certification audits, customer audits, and technical inquiries related to sterilization and sterility assurance • Partner with external microbiology laboratories and specialized Sterilization/Microbiology SMEs • Support manufacturing process validation activities, including IQ, OQ, and PQ • Provide Quality Engineering support for manufacturing processes, process changes, equipment qualification, and technology transfers • Review and approve validation protocols, reports, engineering studies, and associated quality records • Support nonconformance investigations, deviations, CAPAs, and root cause analysis • Participate in manufacturing and process risk management activities, including PFMEAs and change assessments • Apply appropriate statistical techniques to validation, process monitoring, and problem-solving activities • Partner with Operations, Engineering, Supplier Quality, Regulatory Affairs, and other Quality functions • Support continuous improvement and risk-reduction initiatives • Establish strong internal ownership of Sterility Assurance while leveraging external laboratories and specialized SMEs • Ensure sterilization processes remain validated and compliant while providing hands-on Quality Engineering and Validation support

🎯 Requirements

• Bachelor's degree in Engineering, Life Sciences, Microbiology, or a related technical discipline • 7+ years of Quality Engineering, Validation, Sterility Assurance, or related experience within the medical device industry • Demonstrated experience with medical device sterilization processes, preferably including EO and radiation sterilization • Strong experience with process validation and maintenance of validated processes • Working knowledge of ISO 11135, ISO 11137, ISO 11737, ISO 13485, and FDA medical device Quality System requirements • Experience investigating sterilization deviations, process excursions, nonconformances, and CAPAs • Experience working with contract sterilization providers and/or external testing laboratories • Ability to independently assess technical information, make risk-based recommendations, and clearly document conclusions • Strong cross-functional communication and technical writing skills • Experience with both EO and gamma radiation sterilization • Experience with sterilization cycle transfer, duplication, or establishment of new sterilization cycles • Experience with bioburden trending and microbiological control programs • Experience with radiation dose audits and dose-maintenance programs • Experience supporting regulatory or Notified Body audits involving sterilization • Experience in contract manufacturing or multi-site medical device environment • ASQ CQE or other relevant Quality/Validation certification

🏖️ Benefits

• Medical insurance • Prescription drug insurance • Dental insurance • Vision insurance • Flexible spending accounts • Participation in 401(k) savings plan • Paid time off (PTO) • Short-term disability • Long-term disability • Parental leave