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Design Quality Engineer - Fairfield, NJ in Fairfield, NJ at Getinge

Date Posted: 6/16/2019

Job Snapshot

  • Employee Type:
  • Location:
    Fairfield, NJ
  • Experience:
    Not Specified
  • Date Posted:

Job Description

Position Overview:

Provides leadership and technical support for the quality assurance, process control, and engineering functions with an emphasis on design control.  Leads or is a key contributor to cross functional process improvement and problem solving teams. Ensures compliance to regulatory requirements per CFR820 and MAQUET policies and procedures for design control.

Job Details:

  • Participate in the new product development process by ensuring that all the quality data streams are fully comprehended and that the voice of the customer, as heard through these data streams (complaints, non-conforming material records [NCMRs], verified failures, etc.), is a design input and consideration.
  • Participate in development of potential hazards associated with new designs through review of predicate products and lessons learned from predicate product lifecycles.
  • Provide subject matter expertise and ownership for Risk Management activities, including, the comprehensive and accurate assessment and characterization of design risks, which includes both the appropriate mitigation activities and proper identification in downstream design outputs (design failure modes and effects analysis [DFMEA], Critical To Quality and Critical To Process characteristics on specifications, Risk Assessments for issues impacting distributed product, etc.).
  • Represent the QA/QE function for the review and approval of designated design outputs.
  • Support the implementation of the Reliability Program for application in new product development and utilization in predictive models for issue characterization.
  • Define the appropriate field performance trending metrics, establishing standardized reporting mechanisms, analyzing results to identify emerging trends and improvement opportunities for production and post-production monitoring of new products after launch.
  • Participate in the CAPA process as task owner/contributor as appropriate and necessary.
  • Provide Quality leadership to drive the timely resolution of quality issues impacting assigned product lines (typically assigned the most complex and/or business critical issue resolution activities).
  • Support material review board (MRB)/non-conforming material processes as needed.
  • Maintain 100% compliance to Quality Management System processes and procedures.

Background Experience:

  • A Bachelors degree in Engineering, Science or related field is required. A Masters of Science in Engineering, Science or related field is preferred. CQE (Certified Quality Engineer) or CQA (Certified Quality Auditor) is desirable.
  • A minimum of five years’ experience in quality assurance, quality engineering or related functions or a M.S. plus 3 years’ experience is required.
  • A minimum of 2 yrs. design control experience preferred. 
  • Prior experience in a FDA regulated industry or ISO certified organization

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.