Senior Supplier Quality EngineerThe Senior Supplier Quality Engineer is responsible for supporting the Supplier Quality organization by overseeing components, materials, and services provided by suppliers. This role ensures that suppliers meet all regulatory and quality requirements, collaborates with internal teams, and drives continuous improvement in supplier performance.KnowledgeWorking knowledge of Medical Device Regulations/In Vitro Diagnostic Regulation (as applicable), cGMP, CFR 820, ISO-13485, ISO-14971, ISO-9001Quality System Regulation and risk managementValidations (IQ, OQ, PQ) and root cause analysis (CAPA process)Project management techniquesMeasurement system analysis (GR&R, AAA)Statistical Process Controls (SPC) and statistical samplingPPAP (Production Part Approval Process) knowledge (desirable)Familiarity with applicable regulations (FDA, Canada, Brazil, Japan, etc.)SkillsEffective written and verbal communication at all organizational levelsProficiency in problem-solving tools (SPC, TQM, etc.)Analytical skills to evaluate data and situations, translating them into actionable plansAbility to communicate ideas and approaches through proposals, plans, and presentationsHigh proficiency with Microsoft Office suite for reporting and data analysisAbility to manage multiple complex projects simultaneouslyAbility to work independently and collaborativelyISO 13485 lead auditor certification (preferred)Proficiency in English (written and oral); a second language is a plusFamiliarity with tools such as Project, Visio, MiniTab, and Agile (desirable)BehaviorsCollaborative approach with suppliers and internal teamsStrong organizational and follow-up skillsCommitment to continuous improvement and regulatory complianceWillingness to travel domestically and internationally as neededAdherence to safety protocols, including wearing safety shoes in designated areasExperienceMinimum of 5 years of professional experience in similar roles with responsibility for decision-making and problem-solvingRecognized expertise within a similar organizationBachelor's degree in an engineering field (specific discipline may vary based on business needs)ASQ Supplier Quality Engineer Certificate is a plusWhy join Hologic?We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.The annualized base salary range for this role is $98,500 - $154,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.#J-18808-Ljbffr