Sr. Quality Engineer - New Product Development

Senior Design Quality EngineerJoin our team as a Senior Design Quality Engineer where you'll be the guardian of quality for our critical product family, directly protecting patient safety and business risk while driving innovation in medical device development!You'll be working on critical products that directly impact patient lives. Every validation you approve, every risk assessment you complete, and every trend you identify make a difference.ResponsibilitiesQuality Leadership Across the Product Lifecycle: Serve as the Quality Assurance expert for your entire product line, owning Design Control, Document Control, and QA processes from concept to commercializationStrategic Partnership: Collaborate with contract manufacturers and internal plants to seamlessly implement changes while maintaining the highest quality standardsProactive Risk Management: Monitor complaint trends like a detective, identifying performance drift before it becomes a problem and executing swift corrective actionsSubject Matter Authority: Be the go-to resource for cross-functional teams in Engineering, Operations, and supplier managementChampion Design Control Excellence: Serve as the Quality Representative on Project Teams, ensuring Design Control principles are woven into every Product and Process Change and New Product Development initiativeLead Quality Initiatives: Provide QA leadership for Project Teams and the Quality Department.Master Documentation: Build, review, and approve critical Quality System Documents including CAPAs and Audit reportsCraft Compliance Artifacts: Create and approve Design History Files, ensuring every product decision is documented and defensibleValidate Everything: Develop, review, and approve Protocols for Process and Product Validations, Stability studies, and Software Validation documentsAssess and Mitigate Risk: Create comprehensive Risk Assessments using FMEA, FMECA, and FTA methodologiesDevelop Talent: Mentor staff and provide supervision to technicians and engineers, building the next generation of quality professionalsDrive Continuous Improvement: Analyze process and product non-conformances and implement comprehensive corrective and preventive action plans that stickAudit with Authority: Conduct Internal and Supplier Quality System Audits to ensure compliance across the supply chainStay Ahead of the Curve: Maintain active membership in trade and professional organizations, bringing state-of-the-art industry standards back to the teamInvestigate and Resolve: Perform thorough Complaint reviews and investigations, getting to the root cause quicklyTrack Success Metrics: Monitor and trend Quality Indicators to demonstrate continuous improvementCollaborate Across Sites: Work seamlessly with manufacturing facilities and other Division Facilities to ensure quality consistencyChair Critical Reviews: Serve as Independent QA Reviewer and Chairperson for Design Reviews, making the tough calls when neededRequired QualificationsBachelor's Degree in Engineering and 4 Quality Engineering experience in a regulated environment ORMaster's Degree and 2 years of Quality Engineering experience in a regulated environmentKnowledge and SkillsGood questioning and problem-solving skillsDetail oriented and ability to organize large amounts of work and data. This includes the need for good documentation practices.Plans effectively and team oriented.Regulatory knowledge and experience including but not limited to FDA, MDSAP, PMDA, CFDADemonstrated experience working with international suppliers/manufacturers as it relates to product quality and reliabilityDemonstrated history of successfully interpreting regulations, and proceduresDemonstrated skill in statistical analysis and applied statistical methodologiesKnowledge and understanding of IEC 60601 standardsPreferred RequirementsCapital system experience (Electro-mechanical)ASQ CertificationBecton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.#J-18808-Ljbffr