Senior Quality Systems Specialist

Becton Dickinson; Franklin Lakes (NJ); On-site; USD 110,000 - 176,000; Full time

Benefits offered by this job

Annual bonus

Health benefits

Dental coverage

Vision coverage

Life insurance

Job summary

Becton, Dickinson, and Company in Franklin Lakes, NJ is seeking a Quality Systems professional to drive compliance across regulated areas. You will apply quality-system standards to assigned areas and develop solutions for moderately complex tasks.

The role requires a bachelor’s degree in science or engineering and 5+ years of relevant experience, with knowledge of FDA 21 CFR Part 820, ISO 13485 and CAPA processes. BD offers a rich benefits program and a collaborative, growth-focused environment.

Qualifications

• Bachelor’s degree in science, engineering, or related discipline.
• 5 years of relevant experience.

Responsibilities

• Apply quality system standards to assigned area.
• Develop solutions to routine activities of moderate scope.
• Follow procedures and may update procedures.
• Collaborate across functions for quality systems.
• Ensure quality conduct of projects, data interpretation, and reports.

Skills

Quality systems

Regulatory compliance

CAPA

Documentation management

Internal audit

Risk management

Design Controls

Validation

EU MDR/IVDR

Education

Bachelor’s degree in science, engineering, or other relevant discipline

Tools

Computer System Validation

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.

Responsibilities

• Consistent application of quality system standards to assigned quality system area.
• Develops solutions to routine assigned activities of moderate scope & complexity.
• Follows applicable Company/Unit procedures and may make updates to procedures and policies.
• Works within and across functions for assigned quality systems.
• Working knowledge of quality systems regulatory requirements and application to Company/Unit requirements.
• Can ensure quality conduct of projects, including design, data summary and interpretation, and report generation for self and lower level project developers.

Required Qualifications

• Bachelor’s degree in science, engineering, or other relevant discipline 5 years of relevant experience

Preferred Qualifications

• Experience with BD software systems utilized in the Quality Systems Certified Quality Auditor or Transactional Six Sigma Green Belt

Knowledge and Skills

• Working 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).
• Working knowledge of applicable Corporate and/or Unit requirements.
• Able to revise policies and procedures.
• Can independently determine and develop approach to solutions.
• Can develop solutions to routine assigned activities of moderate scope & complexity.
• Must have knowledge/specialization in one or more of the following areas: Calibration, CAPA, Complaints, Computer System Validation, Continuous Improvement, Design Controls, Documentation Management, EU MDR/IVDR, Internal Audit, Label/IFU Controls, Management Review/Controls, Nonconforming Material/Processes, Post-Market Surveillance, Quality Data Analysis, Risk Management, Supplier Quality, Training.

Benefits

• 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

Salary Range for Franklin Lakes, NJ: 110,200.00 - 176,400.00 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.

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 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 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 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 $110,200.00 - $176,400.00 USD Annual

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.

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.