Medtronic · 1 month ago
Senior Quality Applications Specialist - Microbiologist
Warsaw, IN
Full-time
Onsite
Mid, Senior Level
$94K/yr - $142K/yr
4+ years expMedtronic is a global leader in healthcare technology dedicated to improving lives. The Senior Quality Applications Specialist - Microbiologist will oversee cleaning and endotoxin monitoring systems while ensuring compliance with regulatory standards and providing microbiological support in manufacturing operations.
Artificial Intelligence (AI)BiotechnologyHealth CareHealth DiagnosticsMedical Device
Responsibilities
Serve as the SME for the facility’s cleaning and endotoxin monitoring programs, ensuring compliance with regulatory and internal standards
Oversee routine operations, troubleshooting, and continuous improvement initiatives for these systems
Prepare and deliver comprehensive monthly and yearly reports on environmental monitoring activities and cleanroom certifications
Analyze data trends and recommend corrective actions or improvements as needed
Provide microbiological expertise to support manufacturing areas, including cleanrooms, compressed air systems, laminar flow hoods, and RODI systems
Perform routine assessments and investigations to ensure a controlled and compliant manufacturing environment
Provide mentorship to colleagues in environmental testing practices and methodologies
Collaborate with the validation department to support equipment installations, cleaning validations, and process qualification activities (operational and performance qualifications)
Participate in validation protocol development, execution, and documentation to ensure successful project outcomes
Collaborate with cleanroom experts to proactively identify and prevent environmental challenges and particle contamination, ensuring a consistently world-class, high-standard manufacturing environment that meets all applicable standards
Act as the subject matter expert for product cleaning and endotoxin monitoring systems, overseeing the integrity and compliance of these essential processes
Leverage your technical expertise to support complex projects in this area
Take the lead in our microbial laboratory by conducting specialized microbial testing and spearheading technician training on essential water and environmental assays
Play a pivotal role in ensuring our manufacturing processes for medical devices meet the highest standards of safety and compliance through expert oversight and hands-on mentorship
Drive the success of our product cleaning and endotoxin monitoring programs by initiating critical testing requests for Endotoxin (Endo), Cytotoxicity (Cyto), and Total Organic Carbon (TOC) analyses
Leverage your analytical expertise to generate insightful monthly and yearly trending reports for cleanroom and environmental testing, providing valuable data that shapes our quality strategies and ensures regulatory compliance
Play a key role in validation activities by supporting the development and execution of equipment installation plans and comprehensive reports
Expand your impact by contributing your expertise to operational and performance qualification initiatives as needed, ensuring our systems ISO regulations
Collaborate with vendors to oversee the installation, calibration, and qualification of laminar flow hoods and cleanroom environments
Provide technical guidance on resolving complex environmental issues, ensuring all systems meet stringent regulatory and operational specifications for optimal manufacturing performance
Qualification
Required
Bachelor's degree with 4+ years of work experience in Quality or regulated industry OR Advanced degree with 2+ years of work experience in Quality or regulated industry
Preferred
Proven experience as a microbiologist in manufacturing environments, with specialized proficiency in cleanroom operations, compressed air systems, and RODI systems
Extensive experience in cleaning validation within regulated manufacturing environments
Demonstrated experience in validation of CNC equipment, coordinate measuring machines (CMMs), and packaging equipment within manufacturing environments
Demonstrated experience in Operation and Performance Qualification of CNC, and packaging processes within manufacturing environments
Benefits
Health, Dental and vision insurance
Health Savings Account
Healthcare Flexible Spending Account
Life insurance
Long-term disability leave
Dependent daycare spending account
Tuition assistance/reimbursement
Simple Steps (global well-being program)
Incentive plans
401(k) plan plus employer contribution and match
Short-term disability
Paid time off
Paid holidays
Employee Stock Purchase Plan
Employee Assistance Program
Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
Company
Medtronic
Medtronic is a healthcare technology company that designs and develops AI-based products and solutions for the medical industry.
10001+ employees
H1B Sponsorship
Medtronic has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (349)
2024 (387)
2023 (291)
2022 (310)
2021 (300)
2020 (261)
Funding
Current Stage
Public CompanyTotal Funding
$18.16BKey Investors
NHS EnglandBlackstone Life SciencesTrade Capital Funding
2025-09-15Post Ipo Debt· $1.76B
2024-05-29Post Ipo Debt· $3.24B
2023-03-23Post Ipo Debt· $2B
Leadership Team
Geoffrey Martha
CEO and Chairman Of The Board Of Directors
Linnea Burman
SVP & President, Neurovascular
Recent News
2026-01-09
Beyond Bylines
2026-01-09
2026-01-08
Company data provided by crunchbase