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Quality Assurance Specialist

Job No: HS72
Location: Mascot

Henry Schein Halas is part of the Henry Schein Group of companies, the global leader in its field. In Australia, we are the leading supplier of Dental consumable products and the latest dental equipment and technologies. Sourced from quality manufacturers around the world we endeavour to provide our customers with the best possible product range.

Reporting to the Vice President of Global Quality Assurance and Regulatory Affairs, Henry Schein are looking for an energetic and experience Quality Assurance Specialist to help support, develop and maintain a consistent Quality Management System.

The role will involve reviewing and maintaining or developing and publishing, with support of department heads, appropriate policies and standards on behalf of our business. The role will also monitor and report on compliance of regulatory/QA requirements specific to the Dental and Health industries across both in office and distribution Centre environments.

 

Key Responsibilities

  • Management of the Document Control system, SOP’s, Forms and Work Instructions
  • Manage the site Product Quality Review process
  • Working closely across internal departments to identify and continuously improve the service.
  • Maintaining ISO 9001 certification including the development of ISO 13485 certification in line with certifying and regulatory bodies.
  • Perform tracking and monitoring of CAPA’s, deviations, controlled documents etc.
  • Perform Investigation of customer complaints and apply meaningful CAPA’s
  • Prepare monthly management reporting of the status of RA/QA activities
  • Provide advice and guidance on compliance with regulatory, operational and contractual requirements
  • Maintain key registers, and report on trends and effectiveness of continuous improvement initiatives
  • Responsible for assuring that corrective/preventive actions are established, tracked, trends analysed, and root cause elimination is completed
  • Assist other departments with Quality related documents such as Change Control Risk Assessments protocols etc.

Qualification and experience

  • Quality Assurance and/or equivalent work experience
  • 5+ years experience in a similar position; previously developed and implemented audit programs to meet various regulatory and/or certification standards
  • Clinical experience considered an advantage
  • Demonstrate a high level of problem solving skills and the ability to monitor and support continuous improvement
  • English communication skills are excellent both written and spoken
  • Effective Stakeholder Management skills

What's on offer?

  • Competitive salary package
  • Onsite parking
  • Gym/Health facilities
  • Ongoing Heath and Wellness initiatives
  • Ongoing professional development and training
  • An active social calendar & casual Fridays
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