Join BD as a Senior Quality Systems Specialist in Franklin Lakes, NJ, where you will support the development, improvement, and implementation of quality systems. This full-time role requires a minimum of 4 days of in-office presence per week and offers a competitive salary of $110,200.00 - $176,400.00 USD Annual plus annual and discretionary bonuses.
Requirements
Bachelor’s degree in science, engineering, or another relevant discipline.
Minimum of 5 years of relevant experience.
Working knowledge of FDA medical device quality system regulations and international standards such as 21 CFR Part 820, ISO 13485, MDSAP, and EU MDR/IVDR.
Preferred: Experience with BD software systems utilized in Quality Systems, and Certified Quality Auditor or Transactional Six Sigma Green Belt.
Skills & Responsibilities
Quality standards application: Ensure consistent application of quality system standards and update company policies and procedures.
Problem solving and project support: Develop solutions to assigned activities of moderate scope and complexity and ensure the quality conduct of projects.
Regulatory compliance: Apply working knowledge of quality systems regulatory requirements across functions.
Specialized quality focus: Apply knowledge in areas such as CAPA, internal audits, risk management, design controls, or supplier quality.
Potential transition routes: People from Quality Assurance Analyst, Compliance Specialist, or Validation Engineer roles may bring regulatory knowledge and analytical skills, alongside meeting the degree and medical device experience requirements.
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
Summary:
The Sr. Quality System Specialist 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, and project teams for project teams for process improvement and continuous improvement activities.
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
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
Family and Medical Leave (FML)
Jury and Witness Duty Leave
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.
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
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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.
