Microbiologist (Onsite)

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

Work Flexibility: Onsite 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. USN: $69,500 - $110,900 USD Annual Travel Percentage: 10%.

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.

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability. Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

Stryker is one of the world's leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com

Work Flexibility Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location.

Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based.

Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements.

Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.