Job SummaryThe Senior Global Quality Engineer - Sterilization is a subject matter expert responsible for the technical oversight, validation, and lifecycle management of gamma irradiation sterilization processes for SaniSure's products across a global manufacturing and supply network. This role ensures sterilization processes remain compliant with applicable international standards (ISO 11137, ISO 13485, ISO 14937, 21 CFR 820/210/211) and supports new product introductions, sterilization dose audits, supplier/contract sterilizer qualification, and continuous improvement initiatives.
Essential FunctionsSterilization Process Ownership & Validation- Lead gamma sterilization validations (IQ/OQ/PQ) including dose mapping, dose setting/establishment (VDmax25, Method 1, Method 2 per ISO 11137-2), and product family bracketing
- Serve as the technical authority for gamma sterilization process design, transfer, and revalidation activities across global manufacturing sites and contract sterilization partners
- Own and maintain sterilization dose audit programs, ensuring timely execution, trend analysis, and corrective actions for non-conformances
- Evaluate bioburden data, product family groupings, and material compatibility to support sterility assurance level (SAL) justification
Regulatory & Standards Compliance- Ensure sterilization processes and documentation comply with ISO 11137 (parts 1-3), ISO 11737 (bioburden/sterility testing), ISO 13485, ISO 14937, and relevant FDA/EU requirements
- Support customer regulatory submissions (510(k), PMA, Technical Files/Design Dossiers) with sterilization validation data and technical rationale
- Represent the organization during audits (Customer, Notified Body) and customer/contract sterilizer audits as the sterilization subject matter expert
- Monitor evolving global sterilization regulations and standards, assessing impact and driving organizational readiness
Supplier & Contract Sterilizer Management- Qualify, audit, and manage relationships with contract sterilization providers globally
- Review and approve supplier validation protocols, dosimetry reports, and change notifications
- Drive resolution of sterilization-related supplier quality issues, deviations, and CAPAs
Change Control, Risk & Continuous Improvement- Assess and approve engineering changes (material, packaging, product design) for sterilization impact
- Lead risk assessments (FMEA) related to sterilization processes and product sterility assurance
- Drive standardization of sterilization validation practices, templates, and best practices across global sites
- Investigate sterilization-related nonconformances, deviations, and complaints; lead root cause analysis and CAPA implementation
Cross-Functional Leadership- Partner with R&D, Regulatory Affairs, Operations, and Supply Chain on new product development and product transfers
- Mentor junior quality/sterilization engineers and provide training on sterilization principles and standards
- Present sterilization program status, metrics, and risks to senior leadership and quality management review boards
Design Quality Assurance- Serve as the Quality representative on cross-functional new product development (NPD) teams, ensuring design control requirements are met throughout the product lifecycle
- Author, review, and approve design control deliverables including design inputs/outputs, risk management files (per ISO 14971), design verification/validation protocols and reports, and design history files (DHF)
- Lead or support Failure Mode and Effects Analyses (dFMEA)
- Support design transfer activities, ensuring manufacturing processes are robust and capable of consistently producing product that meets specifications
- Review and approve engineering changes and assess impact on product quality and validated states
- Support root cause investigations, CAPA, and nonconformance activities tied to design or process issues
- Perform other duties as assigned
Education / Certifications- Bachelor's degree in biological sciences, engineering, or a related field.
Required Experience & CompetenciesEducation & Experience- Bachelor's degree in Engineering, Microbiology, Biomedical Sciences, or related technical field (advanced degree a plus)
- 5-10 years of experience in quality/sterilization engineering within medical device or pharmaceutical manufacturing
- Demonstrated hands-on expertise specifically in gamma irradiation sterilization - dose mapping, dose audits, dose establishment methods (VDmax25, Method 1, Method 2, Method C1)
- Strong working knowledge of ISO 11137-1/-2/-3, ISO 11737-1/-2, ISO 14937, ISO 13485, and applicable FDA (21 CFR 820) and EU MDR requirements
- Experience with contract sterilizer qualification and management (e.g., Sterigenics, Steris, BeamOne, or equivalent)
- Proven experience supporting customer/notified body audits and inspections
- Strong statistical and technical writing skills for validation protocols/reports
- Experience with risk management tools (FMEA) and CAPA/root cause methodologies
Preferred Qualifications- Experience with additional sterilization modalities (EtO, e-beam, X-ray, steam) for cross-modality perspective
- Global/multi-site quality experience across regions with differing regulatory frameworks (US, EU, APAC)
- Six Sigma / Lean certification
- Certified Quality Engineer (CQE) or equivalent certification
- Experience with bioburden testing methodologies and microbiology lab oversight
- Physical/Other Requirements:Ability to travel up to 10-15% (site visits, sterilization vendor audits)
