Quality Engineer Technical Writer

Quality Engineer Technical Writer

12 Jul 2021
Texas, Fortworth, 76101 Fortworth USA

Quality Engineer Technical Writer

Job Description

Creates and maintains Technical documentation for product development.

Summary of Essential Job Duties:

  • Primary responsibility will be to work with Product Development/Management, associates, contractors, and outsourcing firms as applicable to develop product requirements and Technical file Documentation.
  • Collaborates with engineering and manufacturing functions to ensure technical documents are in place.
  • Collaborates with Engineering and Manufacturing to develop and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
  • Must work with all aspects of regulatory affairs (FDA, OSHA, MDR, TGA, ROHS, REACH, PPE others as applicable) and help the organization make appropriate decisions regarding regulatory affairs
  • Works to ensure process and procedures are controlled, accurate in reflecting the current process and meet expectations as defined ISO policies.
  • Will utilize corrective/preventive actions, continual improvement, customer complaints and nonconformances and investigating root cause and effectiveness of actions taken and Post market Surveillance.
  • Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
  • Sound knowledge of process validation, process verification, process monitoring, Gage R&R activities, with ability to document and execute validation / qualification work.

Skills/Qualifications:

  • Excellent organizational and follow-up skills
  • Detailed oriented individual with high energy level
  • Strong problem solving and analytical skill sets
  • Ability to conceptualize interactions of process with regards to integrating for a effective and efficient quality management system as it relates to the organizations goals
  • Self-motivated with a strong sense of urgency
  • Excellent communication skills oral and written
  • Ability to multi-task, organize and prioritize ongoing projects
  • Ability to treat confidential information with sensitivity
  • Must be assertive, objective, and participate and able to work with all levels of Associates
  • Must be flexible with work schedule
  • Must be able to travel
  • Strong leadership skills with the ability to drive the continual improvement process within the organization
  • Strong commitment to quality
  • Microsoft Suite – advanced skills in Excel
  • Ability to work in a fast pace environment
  • Master Control experience a Plus

Education, Certificates, Licenses, Registrations:

  • BS/BA in Engineering or related function, Quality Control Engineer
  • 5 or more years’ experience QMS/ISO/Regulatory experience

Additional Information

We are an Equal Employment Opportunity Employer.

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Job Details

  • ID
    JC16696762
  • State
  • City
  • Job type
    Full-time
  • Salary
    USD N/A N/A
  • Hiring Company
    Hearing Lab Technology, LLC
  • Date
    2021-07-12
  • Deadline
    2021-09-10
  • Category

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