Job DescriptionThe 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.
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
- Family and Medical Leave (FML)
- Jury and Witness Duty Leave
Salary Range for Franklin Lakes, NJ: $110,200.00 - 176,400.00 USD Annual
Primary Work LocationUSA NJ - Franklin Lakes
Additional LocationsWork ShiftSalary Range Information$110,200.00 - $176,400.00 USD Annual
