Senior Quality Applications Specialist - Microbiologist

Medtronic • Warsaw, IN

1d • Onsite

About The Position

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Act boldly. Compete to win. Move with speed and decisiveness. Foster belonging. Deliver results…the right way. That’s the Medtronic Mindset — our cultural norms. Our brand is rooted in action, not just words. The Medtronic Mindset defines the expectations of our culture. Every person here plays a role in bringing it to life. We recognize your extraordinary potential to ensure future generations live better, healthier lives. Step into a pivotal role where you’ll be at the heart of our advanced manufacturing environment, safeguarding both product quality and patient safety. As a leader in the Environment and Microbial disciplines, you’ll ensure our operations not only meet—but exceed—regulatory standards. You’ll have the opportunity to perform specialized microbial testing and orchestrate the dynamic activities of the microbial laboratory. This is your chance to make a direct impact, driving excellence and innovation across our manufacturing processes, while collaborating with a passionate team dedicated to improving lives. Medtronic – Warsaw, IN manufactures spinal implants and Brain/ENT instrument components. In this exciting and fulfilling role the Quality Applications Systems Specialist will serve as the subject matter expert overseeing cleaning, endotoxin monitoring, and environmental programs, providing microbiological support and validation collaboration to ensure compliant, controlled manufacturing operations.

Requirements

• 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

Nice To Haves

• 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.

Responsibilities

• Subject Matter Expertise (SME) – Cleaning and Endotoxin Monitoring Systems 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.
• Environmental Monitoring & Cleanroom Certification Reporting 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.
• Microbiological Support for Manufacturing Operations 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.
• Validation Department Support 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.
• Responsibilities may include the following and other duties may be assigned.
• 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.

Benefits

• Medtronic offers a competitive Salary and flexible Benefits Package
• We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
• 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, and 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), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees