LocationFridley, Minnesota, United States of America; Plymouth, Minnesota, United States of America
Work modeon-site
Typefull-time
SenioritySenior
Company size10,000+ people
First seenOct 4, 2026 · 1w ago
Verified live1d ago
At a glanceSummarised by Seekless from the posting.
Must have8
Lead and execute microbiology and sterility assurance activities for terminally sterilized medical devices, including ethylene oxide and radiation sterilization validations, qualification and requalification, routine process monitoring, and technical reviews.
Provide subject-matter expertise for controlled environments and contamination control, including cleanroom qualification, environmental and utility monitoring, product bioburden, bacterial endotoxin, particulate, sterility, and ethylene oxide residual testing.
Initiate, support, and technically review Microbiology Investigation Reports, nonconformance reports, issue triage records, and CAPAs; apply risk-based problem solving to determine root or presumptive causes, assess product impact, define containment and corrective actions, and verify effectiveness.
Analyze and trend microbiology and sterilization data over appropriate timeframes; prepare periodic reviews, quality metrics, and Tier or management-review content; identify emerging adverse patterns and recommend timely escalation or improvement actions.
Assess changes to products, materials, suppliers, manufacturing processes, packaging or pallet configurations, facilities, utilities, equipment, and controlled environments for impact to sterility assurance, microbiological quality, endotoxin control, and validated process status.
Develop, revise, and maintain protocols, reports, risk assessments, procedures, work instructions, and technical justifications in alignment with applicable regulations, international standards, internal quality-system requirements, and good documentation practices.
Partner across Quality, Operations, Manufacturing Engineering, Facilities, laboratories, suppliers, contract sterilizers, and product-development teams to resolve quality events, support production and product release decisions, execute new-product or transfer activities, and deliver cross-site compliance initiatives.
Support internal and external audits, regulatory inspections, and formal responses; maintain inspection readiness, communicate significant risks through Tier governance, and drive standardization and continuous improvement across site and regional Microbiology and Sterility Assurance processes.
We anticipate the application window for this opening will close on - 10 Oct 2026
About the company
Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.
A Day in the Life
Medtronic’s Global Sterility Assurance (GSA) organization provides end-to-end microbiological quality and sterility assurance support across Medtronic’s manufacturing network. The organization provides governance and subject-matter expertise for microbiology, controlled environments and contamination control, product bioburden and bacterial endotoxin, sterilization process validation and maintenance, sterile release, quality-system compliance, risk management, and support for new-product development and manufacturing transfers. As a member of this team, you will support manufacturing sites in the Central Region, developing strong partnerships with functional groups across numerous OUs and throughout all stages of the device lifecycle.
At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.
Responsibilities may include the following and other duties may be assigned:
•
Lead and execute microbiology and sterility assurance activities for terminally sterilized medical devices, including ethylene oxide and radiation sterilization validations, qualification and requalification, routine process monitoring, and technical reviews.
•
Provide subject-matter expertise for controlled environments and contamination control, including cleanroom qualification, environmental and utility monitoring, product bioburden, bacterial endotoxin, particulate, sterility, and ethylene oxide residual testing.
•
Initiate, support, and technically review Microbiology Investigation Reports, nonconformance reports, issue triage records, and CAPAs; apply risk-based problem solving to determine root or presumptive causes, assess product impact, define containment and corrective actions, and verify effectiveness.
•
Analyze and trend microbiology and sterilization data over appropriate timeframes; prepare periodic reviews, quality metrics, and Tier or management-review content; identify emerging adverse patterns and recommend timely escalation or improvement actions.
•
Assess changes to products, materials, suppliers, manufacturing processes, packaging or pallet configurations, facilities, utilities, equipment, and controlled environments for impact to sterility assurance, microbiological quality, endotoxin control, and validated process status.
•
Develop, revise, and maintain protocols, reports, risk assessments, procedures, work instructions, and technical justifications in alignment with applicable regulations, international standards, internal quality-system requirements, and good documentation practices.
•
Partner across Quality, Operations, Manufacturing Engineering, Facilities, laboratories, suppliers, contract sterilizers, and product-development teams to resolve quality events, support production and product release decisions, execute new-product or transfer activities, and deliver cross-site compliance initiatives.
•
Support internal and external audits, regulatory inspections, and formal responses; maintain inspection readiness, communicate significant risks through Tier governance, and drive standardization and continuous improvement across site and regional Microbiology and Sterility Assurance processes…
Must Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.