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

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.
      • Strong communication skills, both written and verbal
      • Quality Engineering with analysis tools
      • Computer literate
      • Organized file management
      • Management and/or interaction with multilevel staff

      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.