Microbiologist (Onsite)

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.

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: $69500 - $110900 USD Annual

Travel Percentage: 10%

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 contractors legal duty to furnish information.