Quality Improvement Specialist

6 days ago

Sydney, New South Wales, Australia beBeeQuality Full time $100,000 - $130,000
Quality Assurance Associate Role

This is a highly specialized position that focuses on ensuring the quality and regulatory compliance of products and services. As a Quality Assurance Associate, you will play a critical role in elevating our operations by driving quality improvements and mitigating risks.

Key Responsibilities:
  • Lead Day-to-Day QA and RA Functions: You will be responsible for overseeing the day-to-day quality assurance and regulatory affairs functions across Australia, New Zealand, and affiliates.
  • Support Compliance: You will support compliance with ISO 13485 and local regulatory standards to ensure the company's products and services meet the required quality and regulatory standards.
  • Act as Local Subject Matter Expert: You will act as the local subject matter expert for quality processes and risk assessments, providing guidance and support to internal teams and stakeholders.
  • Conduct Internal Audits: You will conduct regular internal audits to ensure adherence to quality processes and identify areas for improvement.
  • Manage CAPAs, NCs, and Quality Records: You will manage corrective actions, non-conformities, and quality records to ensure timely resolution of issues and maintain accurate records.

Requirements:

  • ISO 13485 Expertise: You must have a solid understanding of ISO 13485 and quality systems to effectively perform your duties.
  • Internal Auditing Experience: You should have experience conducting internal audits and managing corrective actions.
  • Communication Skills: You must possess excellent communication skills to effectively collaborate with internal teams and stakeholders.
  • Problem-Solving Skills: You must be a natural problem-solver with a keen eye for detail and ability to think critically.

What We're Looking For:

  • Highly Motivated Individual: You must be a self-motivated individual who takes initiative to drive quality improvements and mitigate risks.
  • Excellent Communication Skills: You must have excellent communication skills to effectively collaborate with internal teams and stakeholders.
  • Strong Analytical Skills: You must possess strong analytical skills to identify areas for improvement and develop effective solutions.

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