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Why join Stryker?
Job description
Stryker is hiring a Microbiologist for our Global Quality and Operations division. This is an onsite role based in Phoenix, Arizona.
As the Microbiologist, you will support and ensure site Sterility Assurance and compliance to ANSI/AAMI/ISO, FDA Quality System Regulation, ISO13485 related to medical device sterilization, microbiology and related product and process controls.
In this onsite role, you will apply microbiology and sterilization expertise across product sterilization, validation, environmental monitoring, and testing activities while partnering with Quality, Operations, Product Development, and external laboratories and vendors.
What you will do
- Support site sterility assurance activities in accordance with applicable FDA Quality System Regulation, ISO 13485, ANSI/AAMI, and ISO requirements for medical device sterilization and microbiological controls.
- Provide technical guidance for product sterilization and disinfection processes using ethylene oxide, vaporized hydrogen peroxide, steam, and other applicable sterilization modalities.
- Execute and support sterilization and cleaning validations, residual evaluations, and related studies to verify product sterility, cleanliness, and process effectiveness.
- Manage microbiological testing activities, including bioburden, bacterial endotoxin, environmental monitoring, and other product testing programs.
- Investigate sterilization, microbiological, environmental monitoring, and testing nonconformances and support implementation of appropriate corrective actions.
- Evaluate sterilization and microbiological requirements against current ANSI, AAMI, ISO, USP, FDA, EPA, and European regulatory standards and incorporate applicable changes into site processes.
- Partner with Quality Assurance, Operations, Product Development, suppliers, laboratories, and other stakeholders to resolve technical issues and maintain compliant sterility assurance processes.
- Identify and implement improvements to sterilization, testing, validation, and microbiological processes that support product quality and operational efficiency.
What you need
Required
- Bachelor of Science in Biology, Microbiology or a closely related life science.
- 3-5 years of medical device or pharmaceutical microbiological or biological testing, or research and development experience that includes product sterilization.
- Demonstrated knowledge of endotoxin and bioburden testing.
- Ability to cross-reference and keep current on relevant ANSI, AAMI, ISO, USP, EPA, EU and related guidelines.
- Demonstrated ability to work on cross-functional teams.
Preferred
- Applied knowledge of microbiological and sterilization concepts, practices, and procedures. These include gamma irradiation and ethylene oxide forms of sterilization.
- Knowledge in analytical chemistry and cleaning validations.
- USN: $69,500 - $110,900 USD Annual
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Click here to learn more about: US Stryker employee benefits Stryker offers innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
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