Quality System Specialist II - Document Control

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

Benefits offered by this job

Annual Bonus

Potential Discretionary LTI Bonus

Job summary

BD in the United States (Franklin Lakes, NJ) seeks a Quality System Specialist II to support development and improvement of Quality Systems. You will participate in guidance, product decisions, and continuous improvement within cross-functional teams.

Responsibilities include managing documents, engineering change orders, and design history files with SAP, ensuring compliance, and contributing to audits. Requirements include a related degree or equivalent experience, and knowledge of quality

Qualifications

• Experience with FDA medical device quality system regulations and ISO standards.
• Ability to apply quality system standards to the assigned area.
• Knowledge of Good Documentation Practices and audits.
• Experience with documentation management, EDRs, and design history files.
• Familiarity with SAP, Docusign, PEGA, Trackwise is desirable.

Responsibilities

• Support Documentation Management for Sustaining Eng and NPD projects using SAP.
• Assist in audits, retrieval of documents, and ensure compliance across programs.
• Develop solutions to routine activities within scope and timelines.
• Follow procedures and update policies as needed.
• Collaborate across functions on quality system activities.

Skills

FDA quality systems

Documentation

Team collaboration

Audits

Quality assurance

Education

High School Diploma + 10 years experience

Bachelor's in science/engineering

Tools

SAP

Docusign

PEGA

Trackwise

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

The Quality System Specialist II 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, Product Development project teams and continuous improvement activities.

Job Responsibilities:

• Supporting the Documentation Management needs for Sustaining Engineering and New Product Development projects. This includes processing of Documents, Engineering Change Orders and Design History Files utilizing SAP software.

• Performing tasks, of moderate complexity, within planned schedules and timelines, supporting document retreival for audits, actively leading or participating on project teams and ensuring documentation compliance.

• Develops solutions to routine assigned activities of limited scope & complexity.

• Follows applicable Company/Unit procedures and may make updates to procedures and policies.

• Works within and across functions for assigned quality system.

Required Qualifications:

• High School Diploma and 10 years experience OR

• Bachelor’s degree in science, engineering, or other relevant discipline and 2 years of relevant experience

Knowledge and Skills:

• Moderate 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).

• Moderate level of application of quality system standards to assigned quality system area.

• Ability to use standard and approved Quality/Compliance methods

• Knowledge in the application of Good Documentation Practices

• Contributes to the completion of milestones associated with specific projects.

• Able to prepare reports, including quantitative/qualitative analysis, summaries, and protocols.

• Able to follow established procedures.

• Able to work within and across functions for assigned quality systems.

• Able to exercise judgement within generally defined practices and policies in selecting methods and techniques for obtaining solutions to problems with broad scope and complexity.

• Can develop solutions to routine assigned activities of moderate scope & complexity.

• Able to provide decisions, recommendations, and results that cause moderate progress in project/program goals and schedules.

• Experience with BD software systems utilized in the Quality Systems is desirable (SAP, Docusign, PEGA, Trackwise).

• Must have knowledge/specialization in Documentation Management

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.

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.

Required Skills

Optional Skills

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Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

Work Shift

At BD, 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.

$110,200.00 - $176,400.00 USD Annual