Staff Quality Systems Specialist I

Regulatory Jobs; Franklin Lakes (NJ); On-site; USD 136,000 - 217,000; Full time

Benefits offered by this job

Annual Bonus

Potential Discretionary LTI Bonus

Phone reimbursement

Job summary

BD in USA NJ - Franklin Lakes seeks a Senior Quality & Regulatory Leader to oversee CAPA, audits, and quality systems across the site. The role requires leading cross-functional teams and ensuring compliance with 21 CFR 820, ISO 13485, and related standards.

Ideal candidates hold a BS in engineering/science with 8+ years of industry experience and possess strong analytical, communication, and problem-solving skills.

Qualifications

• BS degree in Engineering, Science, or related discipline.
• At least 8 years of medical device, biologic, pharmaceutical, or diagnostic industry experience.
• Strong knowledge of US and international regulations (21 CFR 820, ISO 13485, MDD/MDR, MDSAP).

Responsibilities

• Develops site/unit procedures and updates unit policies.
• Acts as Site CAPA Leader and SME for CAPA content and TrackWise use.
• Serves as Site Audit Manager coordinating internal and external audits (FDA, ISO, etc.).
• Coaches and leads CAPA/QA problem-solving across cross-functional teams.
• Tracks quality data trends and reports metrics (CAPA, Audits, QNs).
• Supports Management Review content and continuous improvement of Quality Systems.

Skills

CAPA leadership

Audit management

Quality systems

Regulatory knowledge

Root cause analysis

Data analytics

Cross-functional teamwork

Communication

Education

BS degree in Engineering/Science

Tools

TrackWise

Quality tools

Job description

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 supports your learning, your progress, and your success.

To learn more about BD visit https://bd.com/careers.

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.

Primary Work Location

USA NJ - Franklin Lakes

Work Shift

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You".

Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.

Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Salary Range Information

$135,500.00 - $216,800.00 USD Annual