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Becton Dickinson

Global medical devices, lab equipment supplier

Quality Engineer 1 - EU MDR

Quality EngineeringConfirmed live in the last 24 hours
Full-timeNo salary listed

About the Job

Requirements

  • A bachelor's degree in Science, Technology, Engineering, or Mathematics is required.

Responsibilities

  • Develop physical and functional test requirements to assure specifications and regulations are met.
  • Write, review, and approve protocols, reports, and data.
  • Conduct testing outlined in protocols and test methods.
  • Execute validation studies on equipment and processes, and conduct or participate in complaints investigations.
  • Understand and follow company procedures and regulatory requirements.
  • Participate in and provide input to training on department and division procedures and policies.
  • Analyze design, process, and test data.
  • Prepare and present oral and written project updates and technical discussions.
  • Develop and implement procedures that provide easy-to-follow instructions.
  • Develop sampling plans by applying attribute, variable, and sequential sampling methods, and develop local procedures, test methods, and standards.
  • Develop and implement Statistical Process Control.
  • Lead investigations related to quality problems.
  • Define and manage risk-management plans, risk assessments, and risk-control tools.
  • Facilitate or independently lead non-conforming product investigations, including corrective and preventive actions and product remedial actions.
  • Manage systems assurance, including documentation, testing and inspection, and product and process development.
  • Support Manufacturing, New Product Development, and Regulatory, as applicable, to ensure systems comply with internal and external guidelines and regulations.
  • Identify and lead product and systems continuous improvement initiatives.
  • Communicate across Quality and cross-functionally with R&D, Regulatory Affairs, Manufacturing, Supply Chain, Customer Service, Marketing, and other functions as necessary.
  • Execute design controls and analyze design inputs.
  • Participate in internal and external audits.

Desired Qualifications

  • An engineering degree is preferred.
  • Engineering experience within the medical device or an equivalent regulated industry is preferred.

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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