Senior Sterility Assurance Engineer (Medical Devices)

Teleflex Incorporated; United States; Remote; USD 116,000 - 140,000; Full time

Benefits offered by this job

Medical, prescription, dental and vis

401(k) program

Paid time off (PTO)

Job summary

Ingenyx seeks an experienced Senior Quality Engineer – Sterility Assurance & Validation to own the Sterility Assurance program and oversee EO and radiation sterilization processes. The role includes supporting process validation, equipment qualification, and regulatory compliance across manufacturing.

The successful candidate will coordinate with external labs, contract sterilizers, and SMEs, while maintaining validated state and contributing to continuous improvement.

Qualifications

• 7+ years of Quality Engineering, Validation, Sterility Assurance, or related experience in medical devices.
• Experience with EO and radiation sterilization.
• Strong experience with process validation and maintenance of validated processes.
• Demonstrated ability to investigate sterilization deviations and CAPAs.

Responsibilities

• Own the Sterility Assurance program and provide technical leadership.
• Oversee EO and radiation sterilization processes and qualification protocols.
• Support sterilization cycle transfer, validation, requalification, and maintenance.
• Review sterilization qualification reports, deviations, and CAPAs.
• Coordinate with contract sterilizers and external labs for testing.
• Maintain sterilization procedures, documentation, and regulatory readiness.

Skills

Sterility Assurance

EO & Radiation Sterilization

Quality Engineering

Process Validation

Education

Bachelor's degree in Engineering, Life Sciences, Microbiology

Job description

Ingenyx seeks an experienced Senior Quality Engineer – Sterility Assurance & Validation to own the Sterility Assurance program and oversee EO and radiation sterilization processes. The role includes supporting process validation, equipment qualification, and regulatory compliance across manufacturing.

The successful candidate will coordinate with external labs, contract sterilizers, and SMEs, while maintaining validated state and contributing to continuous improvement.