Quality Technician

The Quality Technician position will coordinate and maintain the Document Control System, Training Program, and the Cal/PM program.  In addition, this individual will also provide quality management systems support and may provide support for related project in other departments.

Responsibilities

  • Maintain, organize and file company-controlled quality documentation, including quality records, manufacturing records and reports
  • Maintain and develop the Controlled Document Master List, ECO log, and other tracking database tools as needed
  • Distribute released controlled documentation and retrieve obsolete documents as required
  • Review each Engineering Control Order (ECO) for completeness and accuracy
  • Preparing ECO packages relating to Quality Systems department
  • Achieve technical and stylistic consistency in written quality documents to prevent contradicting information
  • Support the development and implementation of additional electronic Quality System modules when requested
  • Continually provide guidance to all employees related to document control policies and procedures
  • Archive quality documents and records in accordance with company records retention policy
  • Receive, review for completeness and file all company quality training plans and records timely and accurately
  • Review incoming inspection records for accuracy, completeness and for Quality acceptance
  • Maintain and coordinate Cal/PM activities including maintaining the Cal/PM listing and ensuring instrument and equipment are reviewed as per their schedule
  • Perform other quality systems assignments and projects as assigned
  • Support other department system activities, as assigned

Organizational Relationships

This position reports to the Staff Quality Engineer.

Job Requirements

Education and Training

  • BS in Life Sciences or Engineering preferred
  • Minimum Associate’s degree or equivalent from two-year College or technical school or related experience and / or training

Technical Requirements

  • QA work experience in the medical device industry and experience in Electronic Quality Management System is a plus
  • Experience with FDA requirements, knowledge of regulations such as GMP, ISO 13485 and other international regulatory requirements preferred
  • Good verbal and written communication skills; must interface well with all levels of the organization
  • Must work well with limited oversight and gain independence with experience
  • Must have initiative, judgment, and ability to manage multiple tasks with frequent interruptions with high attention to detail and accuracy
  • Excellent ability to work in a team environment and display a positive, can-do attitude
  • Proficient computer skills (MS Office)
  • Strong work ethic

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