Quality Engineer

Senior Global Quality Engineer – SterilizationSaniSure is a high-growth multinational manufacturer of single-use products and systems used in the production of biological drugs, including cell therapies, gene therapies, and vaccines. With operations in the U.S. and Europe, we supply global pharmaceutical and biotech companies with the critical tools they need to develop and manufacture some of today's most innovative and life-changing medicines.As we continue to expand our product offerings and global footprint, SaniSure offers an exciting opportunity to join a nimble, customer-focused company at the forefront of the biotech industry.The 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 & ValidationLead gamma sterilization validations (IQ/OQ/PQ) including dose mapping, dose setting/establishment (VDmax25, Method 1, Method 2 per ISO 11137-2), and product family bracketingServe as the technical authority for gamma sterilization process design, transfer, and revalidation activities across global manufacturing sites and contract sterilization partnersOwn and maintain sterilization dose audit programs, ensuring timely execution, trend analysis, and corrective actions for non-conformancesEvaluate bioburden data, product family groupings, and material compatibility to support sterility assurance level (SAL) justificationRegulatory & Standards ComplianceEnsure sterilization processes and documentation comply with ISO 11137 (parts 1–3), ISO 11737 (bioburden/sterility testing), ISO 13485, ISO 14937, and relevant FDA/EU requirementsSupport customer regulatory submissions (510(k), PMA, Technical Files/Design Dossiers) with sterilization validation data and technical rationaleRepresent the organization during audits (Customer, Notified Body) and customer/contract sterilizer audits as the sterilization subject matter expertMonitor evolving global sterilization regulations and standards, assessing impact and driving organizational readinessSupplier & Contract Sterilizer ManagementQualify, audit, and manage relationships with contract sterilization providers globallyReview and approve supplier validation protocols, dosimetry reports, and change notificationsDrive resolution of sterilization-related supplier quality issues, deviations, and CAPAsChange Control, Risk & Continuous ImprovementAssess and approve engineering changes (material, packaging, product design) for sterilization impactLead risk assessments (FMEA) related to sterilization processes and product sterility assuranceDrive standardization of sterilization validation practices, templates, and best practices across global sitesInvestigate sterilization-related nonconformances, deviations, and complaints; lead root cause analysis and CAPA implementationCross-Functional LeadershipPartner with R&D, Regulatory Affairs, Operations, and Supply Chain on new product development and product transfersMentor junior quality/sterilization engineers and provide training on sterilization principles and standardsPresent sterilization program status, metrics, and risks to senior leadership and quality management review boardsDesign Quality AssuranceServe as the Quality representative on cross-functional new product development (NPD) teams, ensuring design control requirements are met throughout the product lifecycleAuthor, 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 specificationsReview and approve engineering changes and assess impact on product quality and validated statesSupport root cause investigations, CAPA, and nonconformance activities tied to design or process issuesPerform other duties as assignedEducation / CertificationsBachelor's degree in biological sciences, engineering, or a related field.Required Experience & CompetenciesEducation & ExperienceBachelor'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 manufacturingDemonstrated 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 requirementsExperience with contract sterilizer qualification and management (e.g., Sterigenics, Steris, BeamOne, or equivalent)Proven experience supporting customer/notified body audits and inspectionsStrong statistical and technical writing skills for validation protocols/reportsExperience with risk management tools (FMEA) and CAPA/root cause methodologiesPreferred QualificationsExperience with additional sterilization modalities (EtO, e-beam, X-ray, steam) for cross-modality perspectiveGlobal/multi-site quality experience across regions with differing regulatory frameworks (US, EU, APAC)Six Sigma / Lean certificationCertified Quality Engineer (CQE) or equivalent certificationExperience with bioburden testing methodologies and microbiology lab oversightPhysical/Other Requirements: Ability to travel up to 10–15% (site visits, sterilization vendor audits)Equal Employment Opportunity PolicyWe are committed to providing equal employment opportunities to all employees and applicants without regard to race, religion (including religious dress and grooming practices), color, sex (including childbirth, breast feeding, and related medical conditions), gender identity or expression, sexual orientation, national origin, citizenship status, uniform service member status, pregnancy, age (40 and over), genetic information, disability (mental and physical), or any other protected status in accordance with all applicable federal, state, and local laws.