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Senior Quality Professional

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Sydney, New South Wales, Australia beBeeRegulation Full time $180,000 - $250,000
Senior Quality Professional

We are seeking an experienced Senior Quality Professional to lead our team in achieving the highest quality standards.

This critical position holds overall responsibility for managing and continuously improving quality management systems across various health sectors, integrating global processes where appropriate.

  • Ensuring compliance with regulatory standards (e.g., ISO13485, TGA Medical Device Regulations, QSR, MDR).
  • Implementing quality system components, including document control, management responsibility, quality planning, training, corrective actions, and audits.
  • Acting as the primary contact for regulatory authorities in Australia & New Zealand.

You will work closely with cross-functional teams to drive business growth while maintaining the highest level of quality and compliance.

Key Requirements:
  • Possess a Bachelor's or Master's degree in Engineering, Life Sciences, Quality, or Business Management.
  • Have a strong understanding of industrial product regulations and standards.
  • Have practical knowledge of TGA regulations and other markets like US FDA and EU MDR.
  • Ideally, have 10+ years of quality management experience in manufacturing or commercial environments within medical devices or pharmaceuticals.

We value diversity and inclusion and encourage applicants from all backgrounds to apply. We will accommodate accessibility needs during the application process upon request.

The ideal candidate will possess excellent communication skills, be able to analyze complex data, and develop effective quality strategies to drive business success.

Please note that this is a key role within our organization, and we are looking for someone who can make a significant contribution to our quality initiatives.

As a Senior Quality Professional, you will be responsible for ensuring that our products meet the highest standards of quality and safety, while also driving operational efficiency and regulatory compliance.