Quality Manager

Position Overview

The Quality Manager position develops, implements and manages quality control systems designed to ensure continuous production of advanced medical devices and applications (consistent with established standards, customer specifications and production goals). The position supervises a team of quality control specialists/inspectors and processes.

Essential Job Functions

  • Provides direct Quality production support to ensure on-time delivery to customers while maintaining compliance to organizational quality standards, responsibility for calibration and applicable regulatory standards.
  • Ensure a high level of internal and external customer service. Utilize NCR and CAPA process to Investigate (and correct) quality issues throughout the production and customer complaints
  • Acts as Subject Matter Expert (SME) regarding complaints, CAPAs and NCRs during external (supplier and regulatory agency) audits.
  • Supervise staffs engaged in inspection and testing activities to ensure high productivity and high technical integrity.
  • Assist Sr. management to develop and analyze statistical data and product specifications to determine standards and to establish quality and reliability expectancy of finished products.
  • Provide technical and statistical expertise to teams.
  • Formulate, document and maintain quality control standards and on-going quality control objectives.
  • Coordinate objectives with production procedures in cooperation with other plant managers to maximize product reliability and minimize costs.
  • Create, document and implement inspection criteria and procedures.
  • Interpret quality control philosophy to key personnel within company.
  • Provide, and oversee, inspection activity for product throughout production cycle.
  • Apply total quality management tools and approaches to analytical and reporting processes.
  • Interact with vendors to ensure quality of all purchased parts.
  • Create and direct environmental test functions and applications.
  • Maintain active role on internal continuous improvement teams.
  • Design, develop and implement quality control training programs.

Requirements

  • S. degree or equivalent experience/education combination
  • Minimum of 7 years of related experience in Medical Device Manufacturing
  • Supervisory/management experience
  • Travel is primarily local during the business day, although some out-of-the-area and overnight travel may be expected (less than 15%)

Other Skills/Abilities

  • Technical Capacity
  • Organizational Skills
  • Problem Solving/Analytical
  • Customer/Client Focus
  • Time Management
  • Collaboration
  • Performance Management
  • Leadership
  • Business Acumen
  • Excellent written/verbal communication skills

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Accepted formats: PDF, Word Doc

Accepted formats: PDF, Word Doc