Quality Applications Systems Specialist

We anticipate the application window for this opening will close on - 2 Jan 2026

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

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.

1. 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.

2. 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.

3. 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.

4. 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.

This role is 100% onsite at our Warsaw, IN manufacturing Site.

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.

• Conduct a compliant validation process for quality information technology systems which requires formal validation documentation (including standard operating procedures) under appropriate federal regulations.

• Coordinate activities with clients, programmers/developers and operating personnel, domestic and, as appropriate, global.

• Identify current and anticipated requirements for compliant computerized operations and suggest methods for the identification, implementation and maintenance of the procedures, actions and documentation necessary to assure compliance according to the appropriate federal and international regulations which govern the user's applications.

• Report on the status of validation activities to fulfill regulatory requirements.

• Keep abreast of changing federal and international regulatory requirements, government audit policies, and the availability of current techniques.

• Perform system administration and configuration of quality information technology systems.

Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident in your applicant profile. 

• Bachelor's degree with 2+ years of work experience in Quality or regulated industry OR Advanced degree with 0+ years of work experience in Quality or regulated industry

Nice to Have

• 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.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

Benefits & Compensation
 

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.  We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
 

Salary ranges for U.S (excl. PR) locations (USD):$75, $112,800.00This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: 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).

The following benefits and additional compensation are available to all regular employees: 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).

Regular employees are those who are not temporary, such as interns.  Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below:

Medtronic benefits and compensation plans

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. 
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here.

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

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