Senior Quality Applications Specialist at Medtronic

Warsaw, Indiana, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

Expertise in cleaning and endotoxin monitoring systems as a subject matter expert (SME)
Knowledge of environmental monitoring, cleanroom certification, and microbiological support for manufacturing operations (cleanrooms, compressed air systems, laminar flow hoods, RODI systems)
Experience with validation support, including equipment installations, cleaning validations, process qualifications (operational and performance), protocol development, execution, and documentation
Ability to perform specialized microbial testing, routine assessments, investigations, data trend analysis, and recommend corrective actions
Skills in troubleshooting, continuous improvement, reporting (monthly/yearly), and mentorship/training in environmental testing practices and methodologies (e.g., water and environmental assays)

Responsibilities

Serve as SME for facility’s cleaning and endotoxin monitoring programs, ensuring compliance with regulatory and internal standards; oversee routine operations, troubleshooting, and continuous improvement
Prepare and deliver comprehensive monthly and yearly reports on environmental monitoring activities and cleanroom certifications; analyze data trends and recommend corrective actions or improvements
Provide microbiological expertise to manufacturing areas; perform routine assessments and investigations for cleanrooms, compressed air systems, laminar flow hoods, and RODI systems
Mentor colleagues in environmental testing practices and methodologies
Collaborate with validation department on equipment installations, cleaning validations, and process qualifications; participate in protocol development, execution, and documentation
Collaborate with cleanroom experts to identify and prevent environmental challenges and particle contamination
Lead microbial laboratory: conduct specialized microbial testing and spearhead technician training on essential water and environmental assays
Oversee integrity and compliance of product cleaning and endotoxin monitoring processes; support complex projects

Skills

Key technologies and capabilities for this role

Microbial TestingEndotoxin MonitoringCleaning ValidationEnvironmental MonitoringQuality SystemsRegulatory ComplianceMicrobiologyManufacturing ProcessesSME

Questions & Answers

Common questions about this position

What is the location for this Senior Quality Applications Specialist role?

The role is based at Medtronic's facility in Warsaw, IN, where spinal implants and Brain/ENT instrument components are manufactured.

What is the salary or compensation for this position?

This information is not specified in the job description.

What key skills and expertise are required for this role?

The role requires subject matter expertise in cleaning and endotoxin monitoring systems, environmental monitoring and cleanroom certification, microbiological support for manufacturing operations including cleanrooms and systems like compressed air and RODI, and collaboration on validation activities.

What is the company culture like at Medtronic?

Medtronic's culture is defined by the Medtronic Mindset: Act boldly. Compete to win. Move with speed and decisiveness. Foster belonging. Deliver results…the right way., emphasizing action, innovation, and a collaborative team dedicated to improving lives.

What makes a strong candidate for this Quality Applications Specialist position?

Strong candidates will have expertise as a subject matter expert in cleaning, endotoxin monitoring, environmental programs, and microbiological support, with the ability to oversee operations, analyze data trends, provide mentorship, and collaborate on validations.

Medtronic

Develops and manufactures medical devices and therapies

About Medtronic

Medtronic provides medical technology, services, and solutions to improve patient care. The company develops a variety of medical devices, including pacemakers, insulin pumps, surgical tools, and neurostimulation devices, which help diagnose, prevent, and treat chronic diseases. These products are used by hospitals, clinics, and healthcare professionals around the world. Medtronic stands out from competitors by investing significantly in research and development to create new products and offering additional services like training and patient management programs. The goal of Medtronic is to enhance patient outcomes and lower healthcare costs through its comprehensive range of medical solutions.

Fridley, MinnesotaHeadquarters

1949Year Founded

$3.2MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Sick Leave

Paid Holidays

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Employee Assistance Program

Wellness Program

Risks

Emerging competitors like Fire1 threaten Medtronic's heart failure management market share.

Spine biologics market growth may attract new entrants, increasing competition for Medtronic.

Recent IPOs in medtech indicate rising competition, challenging Medtronic's market position.

Differentiation

Medtronic's diverse product range spans cardiovascular, diabetes, neurological, and surgical technologies.

The company invests heavily in R&D to drive innovation in medical devices.

Medtronic offers comprehensive services, including training and technical support, enhancing product value.

Upsides

Exclusive deal with Kuros enhances Medtronic's orthopedic portfolio and market share.

Growing spine biologics market offers expansion opportunities in spinal fusion and regenerative medicine.

Balloon catheters market growth aligns with Medtronic's recent product launches, boosting cardiovascular presence.

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