INGENYX- Senior Quality Engineer - Sterility Assurance & Validation

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 functions to maintain compliant and capable manufacturing processes.
•    Support continuous improvement and risk-reduction initiatives.

Education / Experience 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:
o    ISO 11135 – Ethylene oxide sterilization
o    ISO 11137 – Radiation sterilization
o    ISO 11737 – Bioburden and sterility testing
o    ISO 13485
o    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.

Specialized Skills / Other Requirements

•    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.

What Success Looks Like
The successful candidate will establish strong internal ownership of Sterility Assurance while effectively leveraging external laboratories and specialized SMEs when deeper expertise is required. This role will ensure that sterilization processes remain validated and compliant while also providing hands-on Quality Engineering and Validation support to the broader manufacturing organization.
This position is well suited for an experienced Quality Engineer who wants to become a key technical leader in Sterility Assurance without moving away from hands-on engineering and problem solving.

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The pay range for this position at commencement of employment is expected to be between $115,500- $140,000, however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.
 
If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.