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Becton Dickinson

Global medical devices, lab equipment supplier

Quality Engineer

Quality EngineeringConfirmed live in the last 24 hours
Full-timeDelran, NJ, USA

About the Job

Requirements

  • A bachelor's degree in Biomedical Engineering, Engineering, or a related field is required.
  • Three years of experience in medical devices and/or a manufacturing environment in a Quality Engineering role or equivalent is required.
  • Knowledge and understanding of quality and manufacturing are required.
  • Knowledge of product development objectives and strategies is required.
  • Experience with statistical software such as Minitab and Microsoft Excel is required.
  • Applied knowledge of FDA Quality System Regulation and ISO 13485 is required.
  • The ability to multitask is required.
  • Project planning skills and the ability to meet internal and external customer needs are required.
  • The ability to work with and motivate people is required.
  • The role requires the ability to lift approximately 25 pounds and stand for long hours on the production floor and/or in the quality control laboratory.

Responsibilities

  • Author, review, and approve quality management system documents and records to support the Delran plant’s quality objectives.
  • Represent quality interests and concerns on project teams and participate in projects to resolve quality problems, reduce areas of high quality costs, and assist suppliers and subcontractors in meeting plant needs.
  • Investigate quality complaints, examine nonconformances, and execute corrective and preventive actions.
  • Lead validation activities, including authoring and executing protocols that support new product development, process improvements, equipment changes, and test method validations.
  • Provide technical and quality engineering support for ongoing manufacturing and sustaining projects.
  • Design and conduct quality engineering studies to identify root causes of nonconformances and drive improvements in processes, tooling, and product design.
  • Lead investigations into quality issues, initiate nonconformance reports, and manage the review and disposition of nonconforming materials through Material Review Board processes.
  • Develop and maintain quality documentation, including inspection plans, test methods, quality standards, and quality control inspection procedures.
  • Review and approve incoming, in-process, and final inspection records, as well as environmental monitoring data, to ensure compliance with quality requirements.
  • Review lot history records for accuracy, completeness, and adherence to regulatory and quality standards.
  • Review and approve customer specifications and product requirements to ensure alignment with quality expectations.
  • Investigate customer complaints, determine root causes, and support corrective and preventive actions.
  • Coordinate and perform calibration activities for measuring and monitoring equipment to maintain compliance and accuracy.
  • Participate in internal and external audits, regulatory inspections, and quality system assessments, supporting ongoing compliance and continuous improvement initiatives.

Desired Qualifications

  • American Society for Quality Certified Quality Engineer certification.
  • ISO 13485:2003 audit training and/or American Society for Quality Certified Quality Auditor certification.
  • Six Sigma Green Belt or Black Belt certification, or similar certification.
  • Experience with software qualification.
  • Experience with textiles.

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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