Senior Quality Engineer, Becton Dickinson, Louisville, CO

Published
Company: Becton Dickinson, 321 S Taylor Ave, Louisville, CO
  • Leading healthcare safety and technologies for more than a century
Title: Senior Quality Engineer
Job Type: Full-time
Job ID: R-380200
Location: Louisville, CO

Job Description

  • The Sr. Quality engineer is responsible for ensuring TTM products are developed and released meeting customer expectation, regulatory requirements, appropriate voluntary standards, and BD policies and procedures.
  • This position will work as a member of a TTM cross-functional project team engaged in ongoing Product Life Cycle technical support.
  • Will serve as a quality representative on project core teams and will work closely with R&D, Operations, Regulatory Affairs, Marketing and Distribution.
  • This position requires a self-directed individual able to handle multiple projects and tasks utilizing a high level of written and oral communication skills.
  • In addition the incumbent may be expected to initiate quality initiative projects,
  • become thoroughly knowledgeable with all aspects of Sustaining Engineering and/or New Product Development projects,
  • and assume personal responsibility for the successful completion of all tasks within the realm of Quality Engineering responsibilities

Essential Duties and Responsibilities (Summary)

  • Participates on Project Team as Quality Representative.
  • Ensures that principals of Design Control are applied to Product and Process Changes and New Product Development.
  • Creates, reviews and approves Quality System Documents (CAPA, Audits)
  • Creates, reviews and approves Product Documents, such as Design History Files
  • Creates reviews and approves Risk Management Files documents such as: Risk Management Report, Hazard Analysis, Risk Benefit Analysis and FMEA’s
  • Provides supervision to technicians and engineers
  • Performs Internal or Supplier Quality System Audits.
  • Ensures compliance to Department and Division procedures.
  • Drives Reliability planning and Quality Planning for New Product Development.
  • Interfaces with manufacturing facility or other Division Facilities.
Qualifications (Summary)
  • Extensive knowledge of medical device regulation, industry or international standard, including management responsibility.
  • Ability to interface with regulatory bodies to present technical information
  • Comprehensive knowledge of quality systems and relationship to business.
  • Understands basic applied statistics, statistical sampling plans, and statistical process control and advanced statistical methodologies such as DOE and Taguchi.
  • Broad knowledge of manufacturing processes.
  • Understands Fundamentals of Engineering Principles.

Education and/or Experience

  • B.S. in Engineering, Engineering Technology, Science or related field a minimum.
  • Minimum 7 years of experience with FDA regulated industry including 3 years on product development programs.
  • 1 - 2 years experience with electromechanical devices
  • American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.), preferred
Detail Information and To Apply DONE
News Boulder Section 02/04/2021 6:19pm CST

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