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Associate Manager, Microbiology & Sterility

$102.6k - $171k
Full-time

Stryker

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 Bachelor’s 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: $102,600 - $171,000 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 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: 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. Manufacturing roles and any role that requires physical presence at the office would qualify under this category. 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.

Vacancy posted 1 day ago
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