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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in microbiology and sterility assurance for medical devices, including validation of sterilization processes and compliance with regulatory standards. Proficient in data analysis, risk assessment, and cross-functional collaboration to ensure product quality and safety.
Highest-signal resume keywords
Microbiology Investigation ReportsEthylene Oxide SterilizationCGMP ComplianceISO Standards KnowledgeData Analysis and Reporting
ATS Keywords
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Hard Skills
Sterilization ValidationContamination ControlBacterial Endotoxin TestingMicrobiological Product-Impact AssessmentRisk AssessmentTechnical DocumentationQuality Metrics AnalysisProcess MonitoringRoot-Cause AnalysisCAPA Management
Soft Skills
Cross-Functional CollaborationProblem SolvingCommunicationInfluencing TeamsPrioritization
Tools & Technologies
Advanced ExcelPower BIMinitabElectronic Quality Management Systems
Certifications & Qualifications
Certified Industrial Sterilization SpecialistAAMI CertificationASQ CertificationLean Certification
Industry Keywords
Medical DevicePharmaceuticalBiotechnologyRegulatory ComplianceFDA RequirementsISO 13485ISO 11135ISO 11137ISO 14644ISO 17665
About the role
Key responsibilities & impact- Lead and execute microbiology and sterility assurance activities for terminally sterilized medical devices
- Perform 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
- Support 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 causes, assess product impact, define containment and corrective actions, and verify effectiveness
- Analyze and trend microbiology and sterilization data; prepare periodic reviews, quality metrics, and Tier or management-review content
- Assess product, material, supplier, manufacturing, packaging, facility, utility, equipment, and controlled-environment changes for sterility-assurance impact
- Develop, revise, and maintain protocols, reports, risk assessments, procedures, work instructions, and technical justifications
- Partner with Quality, Operations, Manufacturing Engineering, Facilities, laboratories, suppliers, contract sterilizers, and product-development teams
- Support quality-event resolution, production and product-release decisions, new-product or transfer activities, audits, regulatory inspections, and compliance initiatives
- Maintain inspection readiness and drive standardization and continuous improvement across regional Microbiology and Sterility Assurance processes
Requirements
What you’ll need- Baccalaureate degree and minimum of 4 years of relevant experience OR Master's degree with a minimum of 2 years relevant experience OR PhD with 0 years relevant experience
- For Baccalaureate degrees earned outside of the United States, a degree satisfying 8 C.F.R. § 214.2(h)(4)(iii)(A) is required
- Experience in medical device, pharmaceutical, biotechnology, or another highly regulated industry
- Demonstrated application of cGMP and quality-system requirements
- Hands-on experience with industrial ethylene oxide and/or radiation sterilization
- Expertise in controlled environments and contamination control, environmental or utility monitoring, product bioburden, bacterial endotoxin testing, sterility testing, or microbiological product-impact assessment
- Working knowledge of FDA requirements and international standards including ISO 13485, ISO 11135, ISO 11137, ISO 11737, ISO 14644, ISO 14698, ISO 17664, ISO 17665, and relevant AAMI or USP guidance
- Experience with microbiology or sterilization investigations, NCMRs, CAPAs, issue triage, root-cause analysis, risk assessments, and effectiveness verification
- Ability to analyze and trend complex data and communicate conclusions through technical reports, dashboards, or management and Tier reviews
- Experience authoring and reviewing validation protocols and reports, periodic reviews, procedures, work instructions, regulatory responses, and inspection-ready technical documentation in an electronic quality or document-management system
- Ability to prioritize multiple compliance and business-critical deliverables, work independently, influence cross-functional teams, and coordinate work across sites, laboratories, suppliers, and contract sterilization partners
- Unrestricted U.S. work authorization at the time of hire and for the duration of employment; sponsorship is not offered for roles below Principal level
- Certified Industrial Sterilization Specialist or other relevant AAMI, ASQ, Lean, or problem-solving certification is preferred
- Advanced Excel, Power BI, Minitab, or comparable analytical-tool experience is preferred
Benefits
Comp & perks- Competitive Salary and flexible Benefits Package
- Short-term incentive: Medtronic Incentive Plan (MIP)
- Health insurance
- Dental insurance
- 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
- Capital Accumulation Plan for Vice Presidents and above, or subject to IRS earning minimums
- Paid sick time for temporary employees, as required by applicable state law
- Reasonable accommodations for qualified individuals with disabilities