Senior Quality Engineer – Sterility Assurance & Validation

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Act as the internal technical authority for the Sterility Assurance program.

• Provide technical supervision of ethylene oxide (EO) and radiation sterilization processes.

• Assist with the transfer, validation, requalification, and maintenance of sterilization cycles in a validated state.

• Evaluate and authorize sterilization qualification and requalification protocols and reports.

• Analyze sterilization cycle deviations, excursions, nonconformances, and change assessments.

• Aid in investigations, root cause analyses, CAPA, and risk assessments for sterilization-related matters.

• Coordinate and review annual Sterility Assurance and bioburden technical evaluations.

• Oversee radiation dose audits, including the review of Quarterly Dose Audit results, as applicable.

• Track bioburden data and trends, coordinating specialized microbiology support as necessary.

• Provide technical guidance for contract sterilizers and assist with supplier qualifications, audits, SCARs, and quality agreements.

• Maintain sterilization procedures, technical documentation, validation records, and ensure required periodic reviews.

• Support regulatory inspections, certification audits, customer audits, and technical inquiries related to sterilization and sterility assurance.

• Collaborate with external microbiology laboratories and specialized Sterilization/Microbiology SMEs.

• Assist with manufacturing process validation activities, including IQ, OQ, and PQ.

• Provide Quality Engineering support for manufacturing processes, process modifications, equipment qualifications, and technology transfers.

• Review and approve validation protocols, reports, engineering studies, and related quality records.

• Support investigations of nonconformances, deviations, CAPAs, and root cause analyses.

• Engage in manufacturing and process risk management activities, including PFMEAs and change assessments.

• Utilize appropriate statistical techniques for validation, process monitoring, and problem-solving activities.

• Collaborate with Operations, Engineering, Supplier Quality, Regulatory Affairs, and other Quality functions.

• Promote continuous improvement and risk-reduction initiatives.

• Establish strong internal ownership of Sterility Assurance while utilizing external laboratories and specialized SMEs.

• Ensure that 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 field.

• 7+ years of experience in Quality Engineering, Validation, Sterility Assurance, or related roles within the medical device industry.

• Proven experience with medical device sterilization processes, ideally including EO and radiation sterilization.

• Significant experience with process validation and maintaining validated processes.

• Familiarity with ISO 11135, ISO 11137, ISO 11737, ISO 13485, and FDA medical device Quality System requirements.

• Background in investigating sterilization deviations, process excursions, nonconformances, and CAPAs.

• Experience collaborating with contract sterilization providers and/or external testing laboratories.

• Ability to independently evaluate technical information, make risk-based recommendations, and document conclusions clearly.

• Strong communication skills and technical writing abilities across cross-functional teams.

• Experience with both EO and gamma radiation sterilization.

• Experience in sterilization cycle transfer, duplication, or the establishment of new sterilization cycles.

• Experience with bioburden trending and microbiological control programs.

• Experience conducting radiation dose audits and maintaining dose programs.

• Experience supporting regulatory or Notified Body audits related to sterilization.

• Experience in contract manufacturing or a 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.