Product Quality Leader

2 weeks ago

Brisbane, Queensland, Australia beBeeQuality Full time $180,000 - $220,000

About Us

We are a mission-driven team focused on saving lives.

We take a fresh approach to addressing sudden cardiac arrest by innovating AED technology and a software platform solution.

Job Summary
  • The Head of Quality will oversee high-quality products and compliant quality management system processes.
Main Responsibilities
  1. This person will lead the Quality team, responsible for:
    1. Serving as Quality System Management Representative:
      1. Establishing, implementing, and maintaining quality management system processes.
      2. Reporting quality system performance and recommending improvements.
      3. Promoting awareness of regulatory and customer requirements throughout the organization.
      4. Leading quality system Management Review meetings.
    2. Ensuring integration of quality system requirements into product design and development activities.
    3. Maintaining quality systems for document control, quality audits, supplier evaluation, equipment calibration, product inspection/testing, nonconforming part control, corrective/preventive action, and risk management.
    4. Evaluating and auditing suppliers, and coordinating corrective actions.
    5. Managing quality system training and personnel training requirements.
    6. Managing the Corrective and Preventive Action (CAPA) process.
    7. Managing internal and external quality audits.
    8. Establishing quality inspection procedures and statistical sampling plans.
    9. Reviewing nonconforming product dispositions and investigating causes.
    10. Maintaining records and lists related to documents and tracking systems.
    11. Investigating product complaints and supporting regulatory agency reporting.
    12. Analyzing product complaint data and preparing summary reports.
    13. Ensuring compliance with changing regulations and standards.
    ,

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