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Quality Assurance Representative

(NDI International Headquarters - Waterloo, Canada)

Posted: Feb. 22, 2010


GENERAL DESCRIPTION:

The Quality Assurance Representative will assist in maintaining and enhancing NDI's quality system

SCOPE OF RESPONSIBILITIES:

Quality

  • Support, maintain and improve established quality processes supporting ISO 9001 and ISO 13485, QSR, FDA, etc.
  • Assist and participate in Registration and Surveillance Audit activities.
  • Conduct Internal and Supplier Audits.
  • Collect, analyze and report on corporate processes related to ISO such as: Non-conforming materials, Corrective Actions, Customer Complaints, Change Control, Training and Supplier Performance, etc.
  • Maintain all aspects of the Calibrated Equipment Program.

Customer

  • Work with Customers, NDI Customer and Technical Support to understand current problems, determine root cause and establish effective preventative measures.
  • Provide customer data and statistics as required.
  • Provide timely follow up to all inquiries.

Regulatory

  • Work with Engineers to understand product requirements.
  • Arrange and conduct product safety testing with external test or certification labs.
  • Solid knowledge of IEC 60601-1, IEC 61010-1, CISPR 11 Class B preferred.
  • Assist regulatory bodies such as UL, Intertek, and CSA with routine follow up inspections.

Manufacturing

  • Support manufacturing by participating in product inspections and resolving product problems.

REQUIREMENTS:

  • Post-secondary education in a technical discipline. (Electronics preferred)
  • Practical experience with regulatory items as described above in a high tech manufacturing environment.
  • Exceptional written and verbal communication skills, advanced experience with office software, solid statistical process control experience.
  • Self starter, organized, goal oriented.

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Application Instructions

Interested candidates are invited to forward a resume and covering letter to:

  Human Resources Department
  NDI
  103 Randall Drive
  Waterloo, Ontario N2V 1C5
  Fax: (519) 884-5184
  Email: careers@ndigital.com

All correspondence will remain on file for six months, and will be held in confidence.

We wish to thank all candidates for their interest, however, only those most qualified will be contacted.

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