Quality System Specialist II - Document Control

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 The Quality System Specialist II 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, Product Development project teams and continuous improvement activities. Job Responsibilities: Supporting the Documentation Management needs for Sustaining Engineering and New Product Development projects. This includes processing of Documents, Engineering Change Orders and Design History Files utilizing SAP software. Performing tasks, of moderate complexity, within planned schedules and timelines, supporting document retreival for audits, actively leading or participating on project teams and ensuring documentation compliance. Develops solutions to routine assigned activities of limited scope & complexity. Follows applicable Company/Unit procedures and may make updates to procedures and policies. Works within and across functions for assigned quality system. Required Qualifications: High School Diploma and 10 years experience OR Bachelor’s degree in science, engineering, or other relevant discipline  and 2 years of relevant experience Knowledge and Skills: Moderate 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). Moderate level of application of quality system standards to assigned quality system area. Ability to use standard and approved Quality/Compliance methods Knowledge in the application of Good Documentation Practices Contributes to the completion of milestones associated with specific projects. Able to prepare reports, including quantitative/qualitative analysis, summaries, and protocols. Able to follow established procedures. Able to work within and across functions for assigned quality systems. Able to exercise judgement within generally defined practices and policies in selecting methods and techniques for obtaining solutions to problems with broad scope and complexity. Can develop solutions to routine assigned activities of moderate scope & complexity. Able to provide decisions, recommendations, and results that cause moderate progress in project/program goals and schedules. Experience with BD software systems utilized in the Quality Systems is desirable (SAP, Docusign, PEGA, Trackwise). Must have knowledge/specialization in Documentation Management At 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 Bonus Potential Discretionary LTI Bonus   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