Senior Quality Director

1 week ago

Sydney, New South Wales, Australia beBeeQuality Full time $175,000 - $225,000

Key Leadership Role:

The position of Senior Quality Director is now available within our organization. As a senior leader, you will be responsible for developing and implementing the quality strategy across the Zone, ensuring compliance with local and international regulations.

Your Responsibilities

  • Develop and lead the Quality team, promoting a culture of excellence and continuous improvement.
  • Promote a risk-based approach to quality management, ensuring all processes are aligned with regulatory requirements.
  • Establish effective relationships with key stakeholders, including business leaders, customers, and regulatory bodies.
  • Develop and implement policies and procedures that ensure product quality and customer satisfaction.
  • Lead the post-market surveillance activities, ensuring products meet regulatory requirements and addressing any quality issues that may arise.
  • Direct the audit and CAPA programs, ensuring corrective actions are taken promptly to address any quality issues.
  • Develop and manage the quality budget, ensuring efficient use of resources while meeting regulatory requirements.
  • Ensure the quality organization is aligned with the overall business strategy, driving business growth and revenue.
  • Manage and develop the quality organization, fostering a culture of excellence and innovation.
  • Maintain strategic relationships with regulatory bodies, staying up-to-date on changing regulations and ensuring compliance.
  • Foster a culture of quality awareness throughout the organization, encouraging employees to take ownership of quality initiatives.

Requirements

  • Bachelor's degree in a relevant field, such as life sciences, engineering, or medicine.
  • Minimum 10-15 years of experience in a senior leadership role, with a strong background in quality management and regulatory affairs.
  • Advanced knowledge of ISO 13485, 9001, and 14971, with experience in implementing these standards in a regulated environment.
  • Proven track record of leading teams and driving business growth through quality initiatives.
  • Excellent communication and interpersonal skills, with the ability to build relationships with diverse stakeholders.
  • Strong problem-solving skills, with the ability to analyze complex quality issues and develop effective solutions.

About Us

We are a healthcare company dedicated to improving lives through innovative solutions. We value our employees' contributions and offer a dynamic work environment that fosters growth and development.

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