Senior Quality Engineer – Sterility, Validation & Remote

Teleflex; Boston (MA); On-site; USD 116,000 - 140,000; Full time

Job summary

Teleflex seeks a Senior Quality Engineer to lead Sterility Assurance & Validation for sterilization processes. The role focuses on maintaining validated EO and radiation sterilization, overseeing contract providers, and enabling quality systems compliance.

The ideal candidate has 7+ years in medical device quality, strong technical writing, and cross-functional collaboration skills to drive risk reduction and process validation efforts.

Qualifications

• Bachelor's degree in Engineering, Life Sciences or related field.
• 7+ years in Quality Engineering, Validation or Sterility Assurance in medical devices.
• Experience with EO and radiation sterilization processes.
• Familiarity with ISO 11135/11137/11737/13485 and FDA QSR.

Responsibilities

• Maintain and oversee Sterility Assurance programs and contract sterilizers.
• Lead validation activities (IQ/OQ/PQ) and CAPA investigations.
• Collaborate across QA, Regulatory, and Operations to ensure compliant processes.

Skills

Sterility Assurance

Quality Engineering

Validation

Technical writing

Education

Bachelor's degree in Engineering or Life Sciences

Tools

EO sterilization

Gamma radiation sterilization

Job description

Teleflex seeks a Senior Quality Engineer to lead Sterility Assurance & Validation for sterilization processes. The role focuses on maintaining validated EO and radiation sterilization, overseeing contract providers, and enabling quality systems compliance.

The ideal candidate has 7+ years in medical device quality, strong technical writing, and cross-functional collaboration skills to drive risk reduction and process validation efforts.