Engineer Group Lead Quality

Position Overview

Lead multiple quality assurance projects to support the manufacture of medical devices. Lead a group of technicians and engineers. Work closely with manufacturing process changes, product design improvements, implementation of new products and the enhancement of quality system compliance. Job duties:
  • Lead a group of technicians and engineers that support the manufacture of medical devices.
  • Provide leadership in working with manufacturing Engineering and R&D to review process changes and resolve quality issues.
  • Lead activities to establish the disposition and corrective actions associated with nonconforming product and customer complaints.
  • Effectively communicate and collaborate with other departments as needed to achieve Quality Assurance and company goals.
  • Lead projects to improve quality systems including projects that involve software-based systems which collect and manage data.
  • Work with suppliers to maintain high quality levels of incoming production materials.
  • Conduct quality audits within the company and at supplier locations.
  • As assigned, maintain various quality systems such as CAPA, supplier quality, equipment calibration, internal auditing, and quality metrics data analysis.
  • Perform other duties and responsibilities as assigned.

Job Details

    1. Bachelor’s degree in related field or equivalent, advanced degree preferred.
    2. Minimum of ten (10) years of related experience.
    3. Medical device industry experience required.
    4. Good written and verbal communication skills.
    Desired Qualifications
    1. Excellent command of FDA and ISO medical device quality system requirements.
    2. Excellent ability to provide technical leadership in evaluating product quality issues.
    3. Excellent knowledge of medical product manufacturing and quality control.
    4. Ability to understand the technology related to MicroVention’s products.
    5. Computer skills including MS Word, Excel and statistical software (preferably Minitab).
    6. Experience with software used to manage quality information.
    7. Management and/or leadership experience desired.