Staff Quality Systems Specialist I
BD —Franklin Lakes, NJ
- $135,500 - $216,800 a year
- Bachelor of Science
- Children
- Older adults
- Wellness program
- Commuter assistance
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- $85,000 - $100,000 a year
- Full-time
- Remote
- Azure
- 5 years
- Windows
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Polish & Slavic Federal Credit Union —Fairfield, NJ
- $20.00 - $27.03 an hour
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5d
IT Support
Kulite Semiconductor Products, Inc. —Leonia, NJ
- $55,000 - $60,000 a year
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Team Tranquil Software Solutions —Fairfield, NJ
- Email
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Langan Engineering & Environmental Services —Parsippany-Troy Hills, NJ
- $26 - $35 an hour
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- Computer science
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Fabrication Enterprises Inc —Elmsford, NY
- $120,000 a year
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Backend Software Engineer - AI Trainer
DataAnnotation —Jersey City, NJ
- $50 - $100 an hour
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Business System Analyst with a fixed income background- 019-26MO
Combined Computer Resources —Newark, NJ
- $75 - $85 an hour
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DataAnnotation —Linden, NJ
- $50 - $100 an hour
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Compliance & Impact Associate
Leviticus Fund —Tarrytown, NY
- $62,000 - $72,000 a year
- Email
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- Office
- Finance
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13h
Security Integration & Security Systems Engineer
Care Security Systems Inc. —New York, NY
- $30 - $40 an hour
- 8 hour shift
- System design
- Mid-level
- In-person
- Health insurance
- Dental insurance
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System Engineer, Contract Compliance and Document Management
NYNJ Link Developer LLC —Elizabeth, NJ
- $68,000 - $72,000 a year
- Full-time
- Background check
- Mid-level
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- Health savings account
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Programmer-Analyst
Purchase College —Purchase, NY
- $60,000 - $70,000 a year
- Full-time
- Mid-level
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8d
Information Technology Engineer- Network
LiveOnNY —Long Island City, NY
- $110,000 - $145,000 a year
- Full-time
- Hybrid work
- Computer science
- 7 years
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Information Technology Engineer- Cloud Data (Architect, SQL Server Administration, Data Gateway)
LiveOnNY —Long Island City, NY
- $110,000 - $145,000 a year
- Full-time
- Hybrid work
- 7 years
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Mechanical/Electrical Maintenance Technician (Commercial Kitchen Exhaust Systems)
The Scientific Group —Long Island City, NY
- $25 - $35 an hour
- Full-time
- OSHA
- Customer service
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- Health insurance
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Staff Quality Systems Specialist I

BD -
Franklin Lakes, NJ

Apply Now

Job Details

$135,500 - $216,800 a year
6 days ago

Benefits

Wellness program
Commuter assistance
Paid parental leave
Health savings account
AD&D insurance
Disability insurance
Health insurance
Dental insurance
401(k)
Flexible spending account
Tuition reimbursement
Military leave
Paid time off
Adoption assistance
Parental leave
Employee assistance program
Vision insurance
Life insurance
Pet insurance

Qualifications

ISO certification process
Defect resolution root cause analysis
Legal analysis
Bachelor of Science
Preventive action implementation
Coaching
Presentations for conferences or internal meetings
Production deviation management
TrackWise
Corrective and preventive actions (CAPA)
Metrics Reporting
Quality improvement leadership
Quality reports
Manufacturing standard operating procedures
Collaboration with product development teams
Bachelor's degree in engineering
Quality assurance standard operating procedures
Task prioritization
Content development
Quality control problem-solving
Interdisciplinary policy and procedure development experience
Biomedical regulatory compliance
Operational excellence initiatives
Application support
Senior level
Regulatory audits
Cross-functional team management
Content review
Communication skills
Policy Development

Full Job Description

Now

Job ID

R-548647

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

Job Responsibilities:

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

Education and Experience:

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

Knowledge and Skills:

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

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

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.

Salary Range Information

$135,500.00 - $216,800.00 USD Annual

Apply Now

Refine Your Search

systems jobs in Lodi, NJ

Staff Quality Systems Specialist I

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