Associate Manager, Microbiology & Sterility

Stryker•Arlington, TN

1d•Hybrid

About The Position

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. This 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.

Requirements

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.

Nice To Haves

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.

Responsibilities

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.