Sterilization QA Lead: Validation & Compliance

B. Braun Medical Inc.

Irvine (CA)

On-site

USD 115,000 - 140,000

Full time

7 days ago

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Benefits offered by this job

Healthcare

401(k) plan

Tuition reimbursement

Job summary

B. Braun Medical Inc. in Irvine, California, is seeking a Senior QA Specialist – Sterilization to oversee sterilization activities and provide technical guidance across manufacturing and laboratory operations.

You will lead validation efforts and develop master plans, ensuring regulatory compliance and product quality. The role requires an 8+ year background in QA, sterilization or microbiology within a regulated setting, strong technical writing, and the ability to partner with internal teams

Qualifications

Bachelor’s degree in microbiology, biology, engineering or related technical discipline.
8+ years in Quality Assurance, sterilization, microbiology or validation in regulated manufacturing.
Experience with sterilization validation and validation reports.
Working knowledge of FDA regulations, ISO standards and QSR.
Strong writing, problem-solving and cross-functional collaboration skills.

Responsibilities

Provide quality oversight and technical guidance for sterilization activities.
Lead validation and revalidation of sterilization equipment, methods and products.
Develop validation strategies, manage schedules, and review protocols and reports.
Resolve complex sterilization and microbiology issues with scientific judgment.
Ensure compliance with procedures, FDA/ISO standards and regulatory requirements.