Senior Quality Systems Specialist

Sr. Quality System SpecialistBD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.The Sr. Quality System Specialist is accountable for support of the continued development, improvement, and implementation of the Quality Systems. This position actively participates in quality guidance, product resolution decisions, and project teams for process improvement and continuous improvement activities.Responsibilities:Consistent application of quality system standards to assigned quality system area.Develops solutions to routine assigned activities of moderate scope & complexity.Follows applicable Company/Unit procedures and may make updates to procedures and policies.Works within and across functions for assigned quality systems.Working knowledge of quality systems regulatory requirements and application to Company/Unit requirements.Can ensure quality conduct of projects, including design, data summary and interpretation, and report generation for self and lower level project developers.Required Qualifications:Bachelor's degree in science, engineering, or other relevant discipline5 years of relevant experiencePreferred Qualifications:Experience with BD software systems utilized in the Quality SystemsCertified Quality Auditor or Transactional Six Sigma Green BeltKnowledge and Skills:Working knowledge of the FDA medical device quality system regulations and international quality system standards/regulations (e.g. - 21 CFR Part 820, ISO 13485, MDSAP, EU MDR/IVDR).Working knowledge of applicable Corporate and/or Unit requirementsAble to revise policies and procedures.Can independently determine and develop approach to solutions.Can develop solutions to routine assigned activities of moderate scope & complexity.Must have knowledge/specialization in one or more of the following areas: Calibration, CAPA, Complaints, Computer System Validation, Continuous Improvement, Design Controls, Documentation Management, EU MDR/IVDR, Internal Audit, Label/IFU Controls, Management Review/Controls, Nonconforming Material/Processes, Post-Market Surveillance, Quality Data Analysis, Risk Management, Supplier Quality, TrainingAt BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.At BD, we are committed to supporting our associates' well-being, development, and success through a performance-based culture. For this position, BD offers a competitive compensation package along with the following benefits specific to this role:Annual BonusPotential Discretionary LTI BonusHealth and Well-being Benefits:Medical coverageHealth Savings AccountsFlexible Spending AccountsDental coverageVision coverageHospital Care InsuranceCritical Illness InsuranceAccidental Injury InsuranceLife and AD&D insuranceShort-term disability coverageLong-term disability insuranceLong-term care with life insuranceOther Well-being Resources:Anxiety management programWellness incentivesSleep improvement programDiabetes management programVirtual physical therapyEmotional/mental health support programsWeight management programsGastrointestinal health programSubstance use management programMusculoskeletal surgery, cancer treatment, and bariatric surgery benefitRetirement and Financial Well-being:BD 401(k) PlanBD Deferred Compensation and Restoration Plan529 College Savings PlanFinancial counselingBaxter Credit Union (BCU)Daily PayCollege financial aid and application guidanceLife Balance Programs:Paid time off (PTO), including all required State leavesEducational assistance/tuition reimbursementMetLife Legal PlanGroup auto and home insurancePet insuranceCommuter benefitsDiscounts on products and servicesAcademic Achievement ScholarshipService Recognition AwardsEmployer matching donationWorkplace accommodationsOther Life Balance Programs:Adoption assistanceBackup day care and eldercareSupport for neurodivergent adults, children, and caregiversCaregiving assistance for elderly and special needs individualsEmployee Assistance Program (EAP)Paid Parental LeaveSupport for fertility, birthing, postpartum, and age-related hormonal changesLeave Programs:Bereavement leavesMilitary leavePersonal leaveFamily and Medical Leave (FML)Jury and Witness Duty LeaveSalary Range for Franklin Lakes, NJ:$110,200.00 - $176,400.00 USD AnnualTo find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you'll discover a culture in which you can learn, grow and thrive.We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.Becton, 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.