Staff Quality Systems Specialist I

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

Benefits offered by this job

Annual Bonus Potential

Medical coverage

BD 401(k) Plan

Life and AD&D insurance

Paid time off

Job summary

Becton, Dickinson and Company (BD) in the USA is seeking an experienced CAPA/audit leader to manage site quality systems and drive CAPA, audits, and QN processes. You’ll coordinate internal and external audits, coach cross-functional teams, and analyze quality metrics to support continuous improvement.

Ideal candidates have a BS in engineering/science and 8+ years in medical device/biologic/pharma settings with strong regulatory knowledge and SME capabilities.

Qualifications

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

Responsibilities

• Develops site procedures and work instructions; updates unit-level procedures as needed.
• Serves as Site CAPA Leader and as SME for CAPA content and TrackWise.
• Leads CAPA Board meetings and coordinates with WW CAPA Board.
• Acts as Site Audit Manager and ensures internal/external audits are completed.
• Supports inspection activities and records responses and closure activities.
• Acts as SME for audit processes and electronic tools utilization.
• Coaches cross-functional teams in problem solving as SME.
• Tracks trends in CAPA, audits, QNs and reports metrics.

Skills

CAPA

Audits

Quality systems

Problem solving

Analytical skills

Regulatory knowledge

Cross-functional collaboration

Communication

Education

BS degree in Engineering, Science, or related discipline

Tools

TrackWise

QMS software

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 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 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.

Benefits

• 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 coverageLong-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

• Salary Range Information $135,500.00 - $216,800.00 USD Annual

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.

Equal Opportunity Employer

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.

Required Skills Optional Skills . Primary Work Location USA NJ - Franklin Lakes Additional Locations 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.

We are the #MakersofPossible Working together, we make products that patients, families and their healthcare professionals rely on. We do this because we are committed to advancing the world of health™. But it takes the imagination and passion of all of us at BD, from manufacturing to marketing, to look at the impossible and find solutions that turn dreams into possibilities with real-life health benefits for people today, tomorrow and beyond. We make this happen, together. We are the makers of possible. 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.