Staff Quality Systems Specialist I

Usa Nj - Franklin Lakeslead

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Quick Summary

Key Responsibilities

Develops applicable Site / Unit procedures / work instructions and may make updates to Unit level procedures and policies.

Technical Tools

OtherSystems

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

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Develops applicable Site / Unit procedures / work instructions and may make updates to Unit level procedures and policies.
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Serves as the Site CAPA Leader
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  Acts as Subject Matter Expert to CAPA end users regarding CAPA content and Trackwise utilization.
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  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
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Serves as the site Audit Manager
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  Collaborates with the PS Internal Audit Program Manager to assess risks and ensure site internal audit requirements are met
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  Ensures systematic execution of all required internal, external (FDA, ISO, etc.) and customer audits
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  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.
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  Acts as Subject Matter Expert regarding audit process and electronic tools utilization.
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Serves as the site coordinator for Quality Notifications (NCs and Planned Deviations)
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  Acts as Subject Matter Expert regarding QN content, process, and electronic tools utilization
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  Supports end users in meeting timely completion of QN related activities
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Leads or supports problem-solving and root cause analysis activities, as needed. Coaches cross-functional teams as a problem-solving subject matter expert.
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Tracks trends of various Quality Data sources (CAPA, Audits, QNs, etc.). Analyzes and reports on metrics.
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Assists with Management Review content development and related activities.
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Maintains Site and WW Quality Systems. Supports continuous improvement initiatives.
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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.

BS degree in in Engineering, Science, or other related discipline
At least 8 years of medical device, biologic, pharmaceutical, or diagnostic industry experience.

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.

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
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 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

What We Offer

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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.