Ward Engineering, HR

777 West Swan Street
Columbus, Ohio 43212
Phone: 614-228-8008, ext. 206

Ward Engineering is currently recruiting for the following positions. To apply, please email your resume to

Manager of Quality and Regulatory Affairs

JOB DESCRIPTION:
Overall control, implementation, and maintenance of the Medical Device quality system and quality procedures in accordance with ISO 13485 and FDA GMP including:

    Quality Assurance and Quality Engineering
    • Communication to management on the state of the quality system.
    • Direct activities of and evaluating performance of quality associates.
    • Administration of document system.
    • Monitor and facilitate design control program, including design specifications, verification, validation and coordination of design history file.
    • Oversee implementation of clinical studies as required for submission to regulatory authorities and notified body.
    • Generate, coordinate, and monitor required regulatory submissions.
    • Perform surveillance and medical device reporting in compliance with FDA regulations.
    • Internal and external audit scheduling and reporting.
    • Administration of CAPA system.
    • Monitor sterilization validation and dose audit processing.
    • Monitor storage and distribution of components and finished goods. Maintain history records.
    • Authorize release of product to distribution after final review of records.
    • Respond to customer quality inquiries.
      Facilities Monitoring
      • Review and approve of maintenance and calibration of equipment.
      • Monitor the preventative maintenance program for manufacturing equipment and facilities.
      • Monitor operating procedures and coordinate training of all personnel.
      SKILLS NECESSARY
      • Strong communication skills, both written and verbal
      • Quality Engineering with analysis tools
      • Computer literate
      • Organized file management
      • Management and/or interaction with multilevel staff

      EXPERIENCE LEVEL
      5-10 years in a pharmaceutical/medical device quality management/regulatory affairs position. Minimum BS Science or Management or equivalent experience in quality assurance positions.