Senior Quality Systems Specialist

BD; Franklin Lakes (NJ); Sur place; USD 110 000 - 176 000; Plein temps

Avantages offerts par ce poste

Annual Bonus

Health benefits

Résumé du poste

BD is a leading global medical technology company. The role involves ensuring quality system standards across assigned areas and developing solutions for moderate scope activities. You will work cross-functionally, applying regulatory requirements (FDA 21 CFR 820, ISO 13485) and updating procedures when needed.

Strong knowledge of quality systems and the ability to independently drive solutions is required, with emphasis on CAPA, risk management, and continuous improvement.

Qualifications

• Bachelor’s degree in science, engineering, or other relevant discipline.
• Experience with quality systems and regulatory requirements.
• Knowledge of CAPA, risk management, design controls and documentation.

Responsabilités

• 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 update procedures and policies.
• Works within and across functions for assigned quality systems.
• Knowledge of FDA medical device quality system regulations and international standards.

Connaissances

Quality Systems

FDA Regulations

CAPA

Risk Management

Training

Formation

Bachelor’s degree in science/engineering or related discipline

Outils

BD software systems

Description du poste

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.

Summary

Job Description

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.

Benefits

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.

Primary Work Location

USA NJ - Franklin Lakes

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

$110,200.00 - $176,400.00 USD Annual