Sterility Assurance & Validation Senior QA Engineer

Teleflex; Massachusetts; Hybrid; USD 116,000 - 140,000; Full time

Benefits offered by this job

Medical insurance

Prescription drug coverage

Dental insurance

Vision insurance

Flexible spending accounts

401(k) savings plan

Paid time off

Disability and parental leave

Job summary

Ingenyx is seeking a Senior Quality Engineer in Sterility Assurance & Validation to act as the internal technical owner for sterilization programs and to support broader Quality Engineering needs.

The ideal candidate has deep medical device QA experience with EO and radiation sterilization, process validation, and strong cross‑functional collaboration to maintain compliant, validated processes across contract sterilizers and external labs.

Qualifications

• Bachelor's degree in Engineering, Life Sciences or related field.
• 7+ years in medical device Quality Engineering/Validation.
• Experience with EO and radiation sterilization.
• Experience with ISO 11135/11137/11737 and ISO 13485.
• Experience working with contract sterilization providers and/or external testing labs.

Responsibilities

• Serve as internal technical owner for Sterility Assurance program.
• Provide oversight of EO and radiation sterilization processes.
• Support sterilization cycle transfer, validation, and maintenance of validated state.
• Review sterilization qualification/requalification protocols and reports.
• Coordinate investigations, CAPAs and risk assessments for sterilization issues.
• Maintain sterilization SOPs, documentation and validation records.
• Support regulatory inspections and supplier audits related to sterilization.

Skills

Quality Engineering

Sterility Assurance

Process Validation

Risk Assessment

Regulatory Compliance

Education

Bachelor's degree in Engineering, Life Sciences, Microbiology

Tools

Minitab

CAPA System

Job description

Ingenyx is seeking a Senior Quality Engineer in Sterility Assurance & Validation to act as the internal technical owner for sterilization programs and to support broader Quality Engineering needs.

The ideal candidate has deep medical device QA experience with EO and radiation sterilization, process validation, and strong cross‑functional collaboration to maintain compliant, validated processes across contract sterilizers and external labs.