Staff Quality Systems Specialist I

We are the people who give possibilities purpose BD 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 Description Job Responsibilities: Develops applicable Site / Unit procedures / work instructions and may make updates to Unit level procedures and policies. Serves as the Site CAPA Leader Acts as Subject Matter Expert to CAPA end users regarding CAPA content and Trackwise utilization. Leads site CAPA Board meetings and liaises with the WW CAPA Board to ensure timely completion of CAPA activities and identify areas of improvement/escalation Serves as the site Audit Manager Collaborates with the PS Internal Audit Program Manager to assess risks and ensure site internal audit requirements are met Ensures systematic execution of all required internal, external (FDA, ISO, etc.) and customer audits Supports pre- and post-inspection activities, which may include but are not limited to hosting and logistics, coaching subject matter experts, record review, and tracking of responses, actions and other audit closure activities. Acts as Subject Matter Expert regarding audit process and electronic tools utilization. Serves as the site coordinator for Quality Notifications (NCs and Planned Deviations) Acts as Subject Matter Expert regarding QN content, process, and electronic tools utilization Supports end users in meeting timely completion of QN related activities Leads or supports problem-solving and root cause analysis activities, as needed. Coaches cross-functional teams as a problem-solving subject matter expert. Tracks trends of various Quality Data sources (CAPA, Audits, QNs, etc.). Analyzes and reports on metrics. Assists with Management Review content development and related activities. Maintains Site and WW Quality Systems.  Supports continuous improvement initiatives. Collaborates with cross-functional partners such as Quality Engineering, R&D, Operations, Medical, Marketing to seek their input into the development of policies and procedures, and their support in addressing Quality Issues. Education and Experience: BS degree in in Engineering, Science, or other related discipline At least 8 years of medical device, biologic, pharmaceutical, or diagnostic industry experience. Knowledge and Skills: Strong knowledge of US and International regulations and standards that apply to the medical device industry including 21CFR820, ISO 13485, MDD/MDR, MDSAP country requirements as well as other requirements applicable to the product. Proficient communication, organizational and interpersonal skills. Ability to perform multiple tasks and prioritize workload. Self-motivated / directed, require minimum supervision Effective analytical, technical, and problem-solving skills. Effective meeting and presentation skills. Ability to perform and/or host internal / external audits. Collaborative ability to work in teams to obtain desired results. 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 Bonus Potential Discretionary LTI Bonus Potential reimbursement of phone use Health and Well-being Benefits   Medical coverage  Health Savings Accounts  Flexible Spending Accounts  Dental coverage  Vision coverage  Hospital Care Insurance  Critical Illness Insurance  Accidental Injury Insurance  Life and AD&D insurance  Short-term disability coverage  Long-term disability insurance  Long-term care with life insurance  Other Well-being Resources   Anxiety management program  Wellness incentives  Sleep improvement program  Diabetes management program  Virtual physical therapy  Emotional/mental health support programs  Weight management programs  Gastrointestinal health program  Substance use management program  Musculoskeletal surgery, cancer treatment, and bariatric surgery benefit  Retirement and Financial Well-being   BD 401(k) Plan  BD Deferred Compensation and Restoration Plan  529 College Savings Plan  Financial counseling  Baxter Credit Union (BCU)  Daily Pay  College financial aid and application guidance  Life Balance Programs   Paid time off (PTO), including all required State leaves  Educational assistance/tuition reimbursement  MetLife Legal Plan  Group auto and home insurance  Pet insurance  Commuter benefits  Discounts on products and services  Academic Achievement Scholarship  Service Recognition Awards  Employer matching donation  Workplace accommodations  Other Life Balance Programs   Adoption assistance  Backup day care and eldercare  Support for neurodivergent adults, children, and caregivers  Caregiving assistance for elderly and special needs individuals  Employee Assistance Program (EAP)  Paid Parental Leave  Support for fertility, birthing, postpartum, and age-related hormonal     changes  Leave Programs   Bereavement leaves  Military leave  Personal leave  Family and Medical Leave (FML)  Jury and Witness Duty Leave  Why 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 supp