Senior Quality Engineer — Sterility & Validation Leader

Teleflex; United States; Vor Ort; USD 116.000 - 140.000; Vollzeit

Benefits dieser Stelle

Health insurance

Dental insurance

Vision insurance

401(k)

Paid time off

Flexible spending accounts

Zusammenfassung

Ingenyx seeks an experienced Senior Quality Engineer – Sterility Assurance & Validation to own sterilization activities, maintain validated processes, and oversee contract sterilizers. You will support microbiological control, risk assessments, and regulatory compliance across the quality system.

The role requires strong technical writing, cross-functional collaboration with Regulatory Affairs and Operations, and hands‑on engineering for EO and gamma sterilization.

Qualifikationen

• Bachelor's degree in Engineering, Life Sciences, Microbiology or a related technical discipline.
• 7+ years of Quality Engineering, Validation, Sterility Assurance, or related experience in medical devices.
• Strong experience with EO and radiation sterilization and with process validation.

Aufgaben

• Act as internal technical owner for the Sterility Assurance program.
• Provide oversight of EO and radiation sterilization processes.
• Support sterilization cycle transfer, validation, and maintenance of validated state.
• Review sterilization qualification and requalification protocols and reports.
• Coordinate and review annual Sterility Assurance and bioburden assessments.
• Oversee supplier qualification and audits of contract sterilizers.
• Maintain sterilization procedures and validation records; support regulatory audits.

Kenntnisse

Sterility Assurance

EO sterilization

Radiation sterilization

Process validation

QA engineering

Risk assessment

Regulatory knowledge

Technical writing

Ausbildung

Bachelor's degree in Engineering

Life Sciences / Microbiology background

Jobbeschreibung

Ingenyx seeks an experienced Senior Quality Engineer – Sterility Assurance & Validation to own sterilization activities, maintain validated processes, and oversee contract sterilizers. You will support microbiological control, risk assessments, and regulatory compliance across the quality system.

The role requires strong technical writing, cross-functional collaboration with Regulatory Affairs and Operations, and hands‑on engineering for EO and gamma sterilization.