Sterility Assurance & Validation: Senior Quality Engineer

Teleflex; Northern (KY); Hybrid; USD 116,000 - 140,000; Full time

Benefits offered by this job

Medical insurance

Dental and vision coverage

401(k) savings plan

Paid time off

Job summary

Ingenyx is seeking a Senior Quality Engineer focusing on Sterility Assurance & Validation. You will own EO and radiation sterilization programs, drive cycle transfer and validation, and support regulatory readiness while partnering with external labs for microbiology and audits.

You will lead quality engineering efforts across sterilization and validation, ensuring compliant processes, CAPAs, and robust documentation in a dynamic medical device environment.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Microbiology or related field.
• 7+ years in Quality Engineering, Validation, Sterility Assurance, or related medical device experience.
• Experience with EO and radiation sterilization processes and validation.
• Strong documentation and risk-based decision making for sterilization.
• Familiarity with ISO 11135/11137/11737 and FDA QMS requirements.

Responsibilities

• Serve as internal technical owner for Sterility Assurance program and oversight of sterilization processes.
• Support cycle transfer, validation, maintenance, deviations, CAPAs and risk assessments.
• Provide QA support for manufacturing validation, IQ/OQ/PQ, and technology transfers.
• Review protocols, reports, investigations, and supplier sterilization activities.
• Collaborate across Operations, Regulatory, Quality, and external labs for audits and compliance.

Skills

Quality Engineering

Sterility Assurance

Validation

EO sterilization

Radiation sterilization

CAPA & root cause analysis

Process validation

Regulatory/compliance awareness

Education

Bachelor's degree in Engineering, Life Sciences, Microbiology

Tools

ISO 11135

ISO 11137

ISO 11737

ISO 13485

FDA QMS knowledge

Job description

Ingenyx is seeking a Senior Quality Engineer focusing on Sterility Assurance & Validation. You will own EO and radiation sterilization programs, drive cycle transfer and validation, and support regulatory readiness while partnering with external labs for microbiology and audits.

You will lead quality engineering efforts across sterilization and validation, ensuring compliant processes, CAPAs, and robust documentation in a dynamic medical device environment.