Quality Engineer

We Are The People Who Give Possibilities PurposeBD 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.Job DescriptionThis position is responsible for authoring, reviewing and approving QMS documents and records, as required, to support BD Delran plant quality objectives. This position will act as the quality representative regarding quality interests and concerns on project teams as well as getting involved in a variety of projects which may include, resolving quality problems, improving areas of high quality costs, assisting suppliers and subcontractors in meeting BD Delran's needs. Be an active team member for investigating quality complaints, examining non-conformances and executing CAPAs.Responsibilities:Lead validation activities, including authoring and executing protocols to support new product development, process improvements, equipment changes, and test method validations.Provide technical and quality engineering support for ongoing manufacturing and sustaining projects.Design and conduct quality engineering studies to identify root causes of nonconformances and drive improvements in processes, tooling, and product design.Lead investigations into quality issues, initiate nonconformance reports (NCRs), and manage the review and disposition of nonconforming materials through Material Review Board (MRB) processes.Develop and maintain quality documentation, including inspection plans, test methods, quality standards, and QC inspection procedures.Review and approve incoming, in-process, and final inspection records, as well as environmental monitoring data, to ensure compliance with quality requirements.Perform thorough reviews of Lot History Records (LHRs) to verify accuracy, completeness, and adherence to regulatory and quality standards.Review and approve customer specifications and product requirements to ensure alignment with quality expectations.Investigate customer complaints, determine root causes, and support corrective and preventive actions.Coordinate and perform calibration activities for measuring and monitoring equipment to maintain compliance and accuracy.Participate in internal and external audits, regulatory inspections, and quality system assessments, supporting ongoing compliance and continuous improvement initiatives.Required Qualifications:Bachelor's Degree in Biomedical/ Engineering or related field.3 years experience in medical devices and/or manufacturing environment, in a Quality Engineering role or equivalent.Knowledge and Skills:Knowledge and understanding of quality and manufacturing.Knowledge of product development objectives and strategies.Experience with statistical software such as Minitab and MS Excel.Applied knowledge of FDA QSR and ISO13485.Good oral and written communication skills.Demonstrated ability to multi-task.Good project planning skills and ability to meet internal/external customer needs.Ability to work with and motivate people.Preferred Qualifications:American Society of Quality Certified Quality Engineer (ASQ CQE)ISO-13485:2003 Audit training and/or American Society of Quality Certified Quality Auditor (ASQ CQA)Six Sigma Green/Black Belt Certification or similarSoftware qualificationExperience with textilesPhysical Demands:Ability to lift approximately 25 poundsAbility to stand long hours on the production floor and/or QC lab.Work Environment:LaboratoryProduction EnvironmentWarehouseAt 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: $83,500.00 - 133,500.00 USD AnnualWhy Join Us?To 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.