Quality Engineering Manager

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Company: dpiX

Location: Colorado Springs, CO 80918

Description:

Position Description:

A full time Quality Engineering Manager is needed to represent and manage the day to day operations of the Quality Management System, as well as represent the Quality Department in product development teams.

  • Support development of testing plans and results analysis in areas such as HAST, x-ray hardness, and lifetime reliability.
  • Support the Risk Management program, including a systemic update to risk analysis.
  • Partner with Operations and Engineering to execute Nonconformance Reporting and Process Deviation handling.
  • Support the execution of the Quality Management System by executing Quality Management Reviews, as well as leading CAPA, Internal Audits, and Technical Review Boards.
  • Review project records and outputs for compliance and accuracy and drive a 'first time right' mentality to support Quality across the organization.
  • Provide Leadership to direct reports.


Major Responsibilities:

  • Provide leadership, direction, and guidance to the Quality and Yield Engineering Teams
    • Ensure that appropriate training and development initiatives are in place so that quality organization team members are properly mentored and have the opportunity to grow personally and professionally
  • Communicate information related to quality management system effectiveness, ensuring all work is in accordance with quality system procedures.
    • Prepare and execute routine Management Reviews, and monitor Quality Actions items to completion
    • Prepare and maintain Dashboard reports on the routine operation of the Quality Management System and Quality Dept programs and projects
  • Acting as Deputy Management Representative:
    • ensure Quality System is established, implemented, and effectively maintained
    • report to top management on Quality System performance and effectiveness
    • promote a culture of quality throughout the organization
    • hosts external quality audits (e.g. ISO and Customer)
  • Work closely with Operations Management to support tactical QA aspect of manufacturing
  • Oversees implementation of quality procedures and protocols that ensure compliance and product reliability.
  • Review and approve product development, bench testing, quality assurance, manufacturing, quality system, marketing, and other regulatory/QMS documents.
  • Maintains outstanding relationships with all key internal customers and external quality/regulatory agencies (eg Notified Bodies). Interacts with the Notified Body on a proactive, independent, and frequent basis.
  • Manages Quality and Yield engineering budget(s).
  • Oversee day to day operation of the eQMS including document/change controls, Training, NCRs, and CAPAs
  • Oversee and execute other elements of the QMS such as RMAs, Complaints, Waivers, Customer Deviations, Reliability/SPC and Quality Issues


Qualifications Desired:
  • Previous experience in the development and execution of quality and regulatory (desired)
  • Working knowledge of ISO 13485/9001, and other relevant requirements (desired)


Education:

Bachelors level required or comparable industry experience (5 + years in Manufacturing and 2+ years of direct report management)

STEM fields preferred

Years Experience:

5+ years experience in a manufacturing environment, semiconductor preferred (desired)

2+ years experience managing individual contributors (required)

Licenses or certifications:

Certified Quality Engineer (CQE) (desired)

Certified Manager of Quality, Operational Excellence (CQM/OE) (desired)

Skills
  • Strong written and verbal communications skills (required)
  • Strong presentation skills are (required)
  • Ability to work independently as well as in a team setting (required)


Other:

Strong knowledge of ISO9001/13485, or similar regulated Quality System environment (required)

Working knowledge of ISO14001 (environmental systems), or equivalent (required)

Working knowledge of ISO14971/31000 (risk management), or equivalent (required)

Salary:

$105,000-$150,000

This full-time position (40+ hr/week) works in office at our Colorado Springs location near the Colorado Springs Airport.

Applications Accepted through: January 6th, 2025.

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