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Quality Engineer

Job in Fairview, Bergen County, New Jersey, 07022, USA
Listing for: Becton Dickinson
Full Time position
Listed on 2026-10-19
Job specializations:
  • Quality Assurance - QA/QC
    Quality Engineering, Regulatory Compliance Specialist
  • Engineering
    Quality Engineering, Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 80000 - 110000 USD Yearly USD 80000.00 110000.00 YEAR
Job Description & How to Apply Below

Becton Dickinson seeks a Quality Engineer for its Delran, New Jersey manufacturing facility. The role involves developing quality documentation, leading validation activities, investigating quality issues, and ensuring compliance with regulatory standards for medical device production.

Responsibilities
  • Author, review, and approve quality management system documents and records
  • Lead validation activities including protocol development for new products and process improvements
  • Design and conduct quality studies to identify root causes and drive process improvements
  • Investigate quality issues, initiate nonconformance reports, and manage Material Review Board processes
  • Review and approve inspection records, environmental monitoring data, and Lot History Records for compliance
Requirements
  • Bachelor's degree in Biomedical Engineering or related field
  • 3+ years quality engineering experience in medical devices or manufacturing
  • Knowledge of FDA QSR and ISO 13485 standards
  • Proficiency with statistical software such as Minitab and MS Excel
  • Strong oral and written communication skills
  • Project planning skills and ability to meet customer needs
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