Expert Lead for Quality Systems

2 days ago

Brisbane, Queensland, Australia beBeeQuality Full time
Lead Quality Management Expert

We are seeking a highly skilled and experienced professional to assume overall responsibility for ensuring high quality products and compliant quality management system processes. This individual will serve as our Quality System Management Representative, leading the Quality team in implementing and maintaining quality systems that meet regulatory requirements.

The ideal candidate will have a strong background in quality management systems, with experience in design, implementation, and maintenance of quality systems for medical product development, manufacturing, distribution, and post-market surveillance. They will be proficient in international medical product regulations and standards, and have a proven track record of organizing, hiring, and developing effective teams.

The successful candidate will be responsible for:

  • Ensuring integration of quality system requirements into product design and development activities throughout the product life cycle;
  • Maintaining quality systems pertaining to document control, quality audits, supplier evaluation, equipment calibration and maintenance, product inspection/testing, nonconforming part control, corrective/preventive action, and risk management;
  • Evaluating, auditing, approving, and monitoring product and service suppliers;
  • Managing Corrective and Preventive Action (CAPA) process to ensure on-time completion of required activities;
  • Managing internal and external quality audits to ensure quality system compliance and effectiveness;
  • Establishing quality inspection procedures and statistical sampling plans;
  • Leading nonconforming product review activities to efficiently disposition affected material;

Additionally, the candidate will be expected to analyze product complaint and post-market surveillance data, and prepare summary reports. A bachelor's degree in engineering or life sciences is required, along with a minimum of ten years of medical product experience.

This is an excellent opportunity for a seasoned quality professional to join our organization and make a meaningful impact. If you are a motivated and detail-oriented individual with a passion for quality management, we encourage you to apply.

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