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Medical Product Quality Assurance Lead

3 weeks ago

Brisbane, Queensland, Australia beBeeQuality Full time $180,000 - $220,000
Lead Medical Product Quality Assurance Specialist

We are a mission-driven team that saves lives by addressing the leading cause of death in the United States: Sudden Cardiac Arrest (SCA).

This person will be responsible for ensuring high-quality products and compliant quality management system processes to support clinical and commercial use of our Company products. They will serve as Quality System Management Representative, including hosting regulatory authority audits.

Key Responsibilities:

  • Serves as Quality System Management Representative, ensuring processes needed for the quality management system are established, implemented, and maintained.
  • Reports to top management on quality system performance and any need for improvement.
  • Ensures the promotion of awareness of regulatory and customer requirements throughout the organization.
  • Runs quality system Management Review meetings including input and output generation.

The ideal candidate will have a strong background in medical product experience, with a focus on design, implementation, and maintenance of quality management systems for medical product development, manufacturing, distribution, and post-market surveillance. They will also possess proficiency in international medical product regulations and standards, as well as application of statistical techniques for manufacturing and quality systems.

Required Qualifications:

  • BS Engineering or life sciences degree required.
  • Minimum ten years of medical product experience.
  • Experience in design, implementation, and maintenance of quality management systems for medical product development, manufacturing, distribution, and post-market surveillance.
  • Proficiency in international medical product regulations and standards.
  • Proficiency in application of statistical techniques for manufacturing and quality systems.

Preferred Skills:

  • Ability to work well under pressure and meet multiple deadlines while maintaining a cooperative working relationship with other people.
  • Ability to work in a highly detailed environment where mental focus and accuracy of work output is essential.
  • Good organizational and oral and written communication skills, including ability to represent the company to both internal and external audiences.

As an equal employment opportunity employer committed to diversity and inclusion, we will provide reasonable accommodations for qualified individuals with disabilities.

Job Description may be subject to change.