INGENYX- Senior Quality Engineer - Sterility Assurance & Validation (Remote, MA,

Expected Travel : Up to 50%

Requisition ID : 14320

Ingenyx proudly launched as a new, independent company following its divestiture from Teleflex on August 3, 2026.

Ingenyx is a leading global provider of product development and production services for medical device manufacturers. We set ourselves apart with deep expertise, decades of experience, a dedication to design for manufacturability, and extensive, in-house capabilities, which include engineering, regulatory services, material selection and formulation, prototyping, manufacturing, assembly and packaging. We deliver industry-changing innovations and next-generation solutions for extrusions; diagnostic and interventional catheters; balloons and balloon catheters; sheath/dilator sets; specialty sutures, braids and fibers; and bioabsorbable sutures, yarns and resins. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

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Position Summary

We are seeking an experienced Senior Quality Engineer – Sterility Assurance & Validation to serve as the internal technical owner for sterilization and sterility assurance activities while also supporting broader Quality Engineering and process validation needs.
This is a hands-on technical role with responsibility for maintaining validated sterilization processes, providing oversight of contract sterilization providers, supporting microbiological control activities, and ensuring continued compliance with applicable regulatory and quality system requirements.
The ideal candidate brings strong medical device Quality Engineering experience with demonstrated expertise in EO and radiation sterilization, process validation, and sterility assurance.

Principal Responsibilities

Sterility Assurance & Sterilization

- 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 as required.

Quality Engineering & Validation

- 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 funct