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Becton Dickinson

Global medical devices, lab equipment supplier

Senior Supplier Quality Engineer

Quality EngineeringConfirmed live in the last 24 hours
Full-time$110.2k - $176.4k /yr

About the Job

Requirements

  • A B.S. or B.A. degree in an engineering or science field is required.
  • At least 3 years of supplier quality experience in a manufacturing environment regulated by the FDA or ISO is required.
  • A robust understanding of QSR, design control, ISO, product risk management, and Good Manufacturing Practices as defined in CFR 820 is required.
  • Strong people interaction, team-building, leadership, and communication skills, including the ability to deliver effective presentations, are required.
  • A strong background in manufacturing processes, including process development and optimization, is required.
  • Experience managing commodities such as instrument finished goods, optics and lasers, contract manufacturers, PCB assemblies and electronics, sheet metal, machined parts, cabling harnesses, chemistry products, or biological products is required.
  • Project management, analytical, critical thinking, problem-solving, and prioritization skills are required.
  • The candidate must demonstrate innovation and implementation skills.
  • Knowledge of statistics and data analysis to drive data-based results and decisions is required.
  • ISO 9001/13485 lead auditing experience is required.
  • Strong problem-solving skills at both process and product levels are required.
  • The candidate must be able to travel 20%.
  • Experience with SAP, Minitab, and quality systems software such as TrackWise is a plus.

Responsibilities

  • Provide guidance and quality oversight for key suppliers to ensure alignment with Waters quality, regulatory, and industry-standard requirements.
  • Ensure supplier controls meet Waters, FDA, and other applicable regulatory requirements, and identify quality needs, product improvements, and customer requirements.
  • Drive and support new product development and sustaining activities in supplier management, ensuring supplier compliance and capability for qualification, approval, and sustaining activities.
  • Ensure adequate design control documentation and records are maintained to support the design-history lifecycle.
  • Support supplier qualification and approval, including supplier selection, quality planning, risk analysis, critical-to-quality characteristics, supplier specifications and design-for-manufacturing reviews, validations, verifications, quality agreements, supplier history files, and other activities as needed.
  • Support field corrective actions when needed.
  • Partner with suppliers to develop strong business and quality relationships through communication and collaboration.
  • Establish initiatives to support ongoing improvement of Supplier Quality Management Systems.
  • Lead supplier capability assessments.

Desired Qualifications

  • Six Sigma Green Belt certification and/or certification as a Quality Engineer (for example, ASQ) or equivalent is desired; Six Sigma Black Belt certification is preferred.
  • Experience with SAP, Minitab, and quality systems software such as TrackWise is a plus.

About the Company

Becton Dickinson

Global medical devices, lab equipment supplier

BD (Becton, Dickinson and Company) is a global medical technology company that designs, manufactures, and sells medical devices, laboratory equipment, and related services for hospitals, labs, clinicians, and biopharma partners. It operates in four segments: Medical Essentials (medication delivery and specimen management devices), Connected Care (medication management and advanced patient monitoring systems), BioPharma Systems (drug delivery systems for pharmaceutical partners), and Interventional (surgical, endovascular, urological, and critical care products). In addition to devices, BD offers connected software, analytics, clinical education, customer portals, and service programs to support its products. The company’s goal is to help healthcare providers improve patient outcomes by enabling safer and more efficient delivery of care through integrated devices, data, and services across the health ecosystem.

Company size
10,001+
Company stage
IPO
Headquarters
Franklin Lakes, NJ
Founded
1961

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