Position Overview

Develops and implements strategies to enhance product quality and compliance. Manages group leaders, engineers and technicians to lead multiple quality assurance projects that support the manufacture of medical devices. Collaborates closely with management and staff in Manufacturing, R&D, Regulatory and other Quality Assurance areas to support manufacturing process changes, product design improvements, implementation of new products and the enhancement of quality system compliance. Job duties:
  • Working with senior quality management, develops and implements strategies to enhance product quality and compliance.
  • Develops and implements organizational structures for quality engineering groups to enhance performance.
  • Manages group leaders, engineers and technicians that support the manufacture of medical devices.
  • Manages group leaders and quality engineers that work with Manufacturing Engineering and R&D to review process changes and resolve quality issues.
  • Manages experienced quality engineers that lead activities to investigate corrective actions associated with nonconforming product and customer complaints.
  • Effectively communicates and collaborates with other departments as needed to achieve Quality Assurance and company goals.
  • Manages quality engineers that lead projects to improve quality systems including projects that involve software-based systems which collect and manage data.
  • Works with suppliers to maintain high quality levels of incoming production materials.
  • Performs other duties and responsibilities as assigned

    1. Bachelor’s Degree in related field or equivalent.
    2. Minimum of eight (8) years of related experience.
    3. Minimum of two (2) years of management or leadership experience.
    4. Medical device industry experience.
    5. Good communication and interpersonal skills.
    Desired Qualifications
    1. Master’s degree in related field.
    2. Excellent command of FDA and ISO medical device quality system requirements.
    3. Excellent ability to provide technical leadership in evaluating product quality issues.
    4. Excellent knowledge of medical product manufacturing and quality control.
    5. Ability to understand the technology related to MicroVention’s products.
    6. Computer skills including MS Word, Excel, and statistical software (preferably Minitab).
    7. Experience with software used to manage quality information.