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Associate Quality Engineer

Terumo Aortic
locationSunrise, FL, USA
PublishedPublished: 6/14/2022
Manufacturing
Full Time

Job Description

JOB TITLE


Associate Quality Engineer

Contractor


MAIN PURPOSE OF JOB AND OBJECTIVES


Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.


POSITION IN ORGANISATION


Position in organization can be found on the Organizational Chart via the company intranet.


KEY DUTIES


  • Update and maintain Quality Management System (QMS) documentation for ongoing projects.
  • Draft and finalize project-related reports, including compliance and progress documentation.
  • Coordinate and execute documentation updates to ensure accuracy and regulatory compliance.
  • Collaborate with project teams to gather data and integrate quality requirements into deliverables.

DIMENSIONS & LIMITS OF AUTHORITY


COMPANY REQUIREMENTS


  1. Must work within requirements of company handbook and policy statements.

Note: Company Handbook, Policy Statement and Authorization of Limits do not form part of the quality system


QUALITY REQUIREMENTS

  • Maintain awareness of the relevance and importance of activities performed and how they contribute to the achievement of quality objectives.
  • Work within the QMS always, ensure accurate completion of records and highlight issues to immediate supervisor any issues affecting quality.
  • Responsible to ensure facility, processes and documentation always remain in a state of audit readiness.


EH&S REQUIREMENTS


  • Take care of your own health and safety and that of others who may
  • be affected by your actions.
  • Work co-operatively to highlight issues affecting Environmental Health and Safety


QUALIFICATIONS & EXPERIENCE


  • Excellent written and verbal communication
  • Ability to interact with all levels within the organization.
  • Analytical skills for compiling and analyzing data (engineering statistics)
  • Computer and software skills (SolidWorks strongly desired)
  • Light Lifting
  • 4 – year engineering/science degree. No previous experience needed
  • Working knowledge of Lean Manufacturing and Six Sigma a plus
  • Experience and understanding of quality system regulations (e.g. 21CFR820, ISO13485)
  • Strong written, verbal, analytical and interpersonal skills
  • Self-motivated
  • Ability to multitask.
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