INGENYX- Senior Quality Engineer - Sterility Assurance & Validation

Quick Facts

• Expected Travel: Up to 50%

Description

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.

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.

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.

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 (preferred).

Benefits

• Pay range expected at commencement: $115,500–$140,000 (base pay may vary based on market location and experience).
• Total compensation includes medical, prescription drug, dental, and vision insurance; flexible spending accounts; participation in 401(k) savings plan.
• Paid time off benefits such as PTO, short- and long-term disability, and parental leave.