Sterility & Microbiology Specialist (Medical Devices)

Stryker; Phoenix (AZ); On-site; USD 70,000 - 111,000; Full time

Job summary

Stryker, based in Phoenix, is seeking a Microbiologist for its Global Quality and Operations division. This onsite role supports site sterility assurance and regulatory compliance to ANSI/AAMI/ISO, FDA QSR, and ISO13485, covering sterilization, microbiology, and related product controls.

You will apply microbiology and sterilization expertise across product sterilization, environmental monitoring, validation, testing activities and collaborate with Quality, Operations, Product Development, and

Qualifications

• Bachelor of Science in Biology or Microbiology; 3–5 years of medical device or pharmaceutical microbiological testing or R&D experience including product sterilization.
• Knowledge of endotoxin and bioburden testing.
• Familiarity with ANSI/AAMI/ISO, FDA QSR, ISO13485 and related guidelines.
• Ability to work cross-functionally in teams.

Responsibilities

• Support site sterility assurance activities per FDA QSR, ISO13485, ANSI/AAMI, and ISO sterilization/microbiological controls.
• Provide technical guidance for product sterilization and disinfection (EO, VHP, steam, etc.).
• Execute sterilization/cleaning validations, residual evaluations, and related studies to verify product sterility and cleanliness.
• Manage microbiological testing activities including bioburden, endotoxin, environmental monitoring, and related programs.
• Investigate sterilization, microbiological, environmental monitoring, and testing nonconformances; support corrective actions.
• Evaluate sterilization/microbiological requirements against ANSI, AAMI, ISO, USP, FDA, EPA, and European standards; update site processes accordingly.
• Collaborate with QA, Operations, Product Development, suppliers, labs to resolve issues and maintain compliant sterility processes.
• Identify and implement improvements to sterilization/testing/validation to boost product quality and efficiency.

Skills

Biology

Microbiology

Education

Bachelor of Science in Biology or Microbiology

Job description

Stryker, based in Phoenix, is seeking a Microbiologist for its Global Quality and Operations division. This onsite role supports site sterility assurance and regulatory compliance to ANSI/AAMI/ISO, FDA QSR, and ISO13485, covering sterilization, microbiology, and related product controls.

You will apply microbiology and sterilization expertise across product sterilization, environmental monitoring, validation, testing activities and collaborate with Quality, Operations, Product Development, and