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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 and monitoring of sterilization processes. Proficient in regulatory compliance, data analysis, 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
MicrobiologySterility TestingContamination ControlRisk AssessmentsValidation ProtocolsEnvironmental MonitoringBacterial Endotoxin TestingProduct Bioburden AssessmentRoot-Cause AnalysisTechnical Documentation
Soft Skills
Problem SolvingCross-Functional CollaborationCommunicationInfluencing TeamsPrioritization
Tools & Technologies
Advanced ExcelPower BIMinitabElectronic Quality Management Systems
Certifications & Qualifications
Certified Industrial Sterilization SpecialistAAMI CertificationASQ CertificationLean Certification
Industry Keywords
Medical DevicePharmaceuticalBiotechnologyRegulatory ComplianceFDA Requirements
About the role
Key responsibilities & impact- Lead and execute microbiology and sterility assurance activities for terminally sterilized medical devices
- Conduct ethylene oxide and radiation sterilization validations, qualification, 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
- Identify emerging adverse patterns and recommend escalation or improvement actions
- Assess changes to products, materials, suppliers, manufacturing processes, packaging, facilities, utilities, equipment, and controlled environments 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
- 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 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
- Bachelor's or advanced degree in microbiology, biological sciences, biomedical engineering, chemical engineering, or a related technical discipline
- Experience in the 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 with advanced Excel, Power BI, Minitab, or comparable analytical tools preferred
- 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
- Certified Industrial Sterilization Specialist or relevant AAMI, ASQ, Lean, or problem-solving certification preferred
- For Baccalaureate degrees earned outside the United States, a degree satisfying 8 C.F.R. § 214.2(h)(4)(iii)(A) is required
- Unrestricted U.S. work authorization required at hire and throughout employment; sponsorship is not offered for roles below Principal level
Benefits
Comp & perks- Competitive salary and flexible benefits package
- Short-term incentive through the 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