Associate Manager, Microbiology & Sterility

Work Flexibility: Hybrid or Onsite

Stryker is hiring an Associate Manager Microbiology & Sterility based in Arlington TN to lead microbiology and sterility assurance efforts across multiple United States Trauma & Extremities manufacturing sites. his role provides people leadership technical direction and cross-site coordination to ensure microbiological controls laboratory testing cleanroom environmental monitoring and sterilization systems are compliant effective and scalable in support of product quality patient safety and regulatory standards. The Associate Manager will partner closely with cross-functional teams to maintain an inspection-ready quality system support new product introductions and drive continuous improvement and operational efficiency across the network.

What you will do

• Support oversight of microbiology and sterility assurance programs across four U.S. T&E manufacturing sites partnering with site quality and operations teams.

• Coordinate cleanroom compliance and environmental monitoring programs including routine trending and issue escalation.

• Assist in management of sterilization programs (validation requalification and maintenance) to ensure consistent and compliant execution.

• Oversee day-to-day activities of an internal microbiology lab (including endotoxin testing) and coordinate external laboratory testing.

• Provide direct supervision and development support to a small team of microbiologists and QC technicians including goal setting and prioritization.

• Review microbiological data investigations and CAPAs to ensure timely scientifically sound and compliant outcomes.

• Support NPI remediation and capacity expansion projects by ensuring microbiology and sterility requirements are incorporated into processes.

• Partner cross-functionally and contribute to audit readiness quality system adherence and continuous improvement of microbiology programs and procedures.

What you will need

Required

• Bachelors degree required in Microbiology Biology Biochemistry Biomedical Sciences Engineering or a related scientific discipline.

• Minimum of 6 years of relevant experience in microbiology sterility assurance or laboratory operations with demonstrated support in medical device pharmaceutical or similarly regulated manufacturing environments.

• Strong technical knowledge of environmental monitoring cleanroom controls microbiological testing endotoxin strategies sterility assurance and sterilization validation / maintenance activities.

• Demonstrated ability to lead investigations root cause analysis CAPA and risk assessments in complex manufacturing and compliance environments with proficiency in Microsoft Office and quality/data systems.

Preferred

• Minimum of 2 years of people leadership or team oversight experience including coaching prioritization and performance management with demonstrated ability to collaborate across multi-site teams and manage internal and external stakeholders while driving continuous improvement initiatives such as Lean cost optimization and in-house laboratory transformations.

• Working knowledge of quality system and regulatory requirements relevant to the role including 21 CFR 820 / QMSR ISO 13485 ISO 11137 and ISO 14644 or comparable standards.

• Experience supporting new product introduction technology transfer process validations or remediation/inspection readiness programs.

• USN: $102600 - $171000 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.