DUTIES AND RESPONSIBILITIES:

  • Has primary responsibility for management of all quality staff and quality-related functions, and for further development of the quality staff and its responsibilities, as dictated by continuing corporate growth
  • Has responsibility for managing, developing, and maintaining a comprehensive quality program that assures conformance of all products and systems to rigorous standards and specifications, and which meets corporate objectives, while conforming to applicable FDA and foreign regulations and guidelines, including ISO 13485, complaint handling and Quality System regulations
  • May assist in preparing and filing regulatory documents with U.S. and foreign authorities necessary to gain market introduction of new products and to review such submissions for technical, medical, scientific, and/or regulatory adequacy and accuracy
  • Has overall responsibility for managing the development of inspection procedures, QC sampling plans, and product/material acceptance and release criteria for company products, and where necessary, for developing quality staff to assure continued conformance of product to specifications, and to meet the demands of continued growth
  • Coordinates activities relating to supplier selection, qualification, and certifications, including supplier audits and first article evaluations, where appropriate, and works closely with Operations staff to establish quality requirements for external suppliers; manage development and maintenance of supplier quality, focused on ensuring that supplier production systems are capable and validated in order to produce conforming product
  • Must be familiar with GD&T, SPC, gauge R&R, and process validation, to assure conformance of product and minimize inspection requirements
  • Performs or coordinates complaint investigation and tracking, corrective and preventive actions, and correspondence related thereto, and provides trending and generates reports as necessary to support Management
  • Responsible for the internal audit program, for tracking corrective actions derived therefrom, and for providing trending, tracking and reporting as necessary to assure corporate compliance with applicable regulations and conformance with the Company quality policy
  • Supports new product development as a core team member, and is responsible for providing quality direction to the process, and for managing the creation and completion of Quality Plans
  • Oversees quality systems including acting as architect/builder of overall QMS
  • Author and update all SOPs
  • Supports Executive Management and the Management Review process by providing trending, tracking, and reporting of company Quality System performance metrics
  • Supports company training programs by providing guidance and expertise in quality system compliance, quality control, and process control capability, statistical techniques, root cause analysis, and other programs and processes related to or impacting the quality of company product.

 

EDUCATION & EXPERIENCE:

  • Bachelors’ degree required; Mechanical or Quality Engineering preferred
  • Masters’ degree, preferred
  • Exceptional and demonstrable written and verbal communication skills.
  • A minimum of ten (10) years’ directly related experience
  • Minimum of five (5) years in senior management/leadership role
  • Experience with, and knowledge of, applicable regulatory paths to market, including 510(k), IDE, PMA, CE Marking, registrations, licensing, and associated foreign and domestic requirements is a plus
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