Quality Assurance Expert

6 days ago

Sydney, New South Wales, Australia beBeeQuality Full time $120,000 - $140,000

Role Summary:

We are seeking a dedicated Quality Assurance professional to join our team in a 12-month parental leave cover role.

This exciting opportunity is ideal for individuals with experience in administering quality management systems, managing quality documentation, and performing internal and supplier audits.

  • Key responsibilities include:
  • Administering quality management systems for the business and relevant entities
  • Managing quality documentation to meet organizational needs in compliance with ISO 9001 requirements
  • Performing internal audits as a lead auditor supporting the internal audit program
  • Performing supplier audits as a lead auditor
  • Monitoring and supporting timely execution of internal and supplier audits
  • Preparing for audits by researching materials, standards, policies, and procedures to formulate a plan of action
  • Recruiting, training, and ensuring competency of a team of internal auditors
  • Ensuring that non-conformities are recorded and resultant actions are effective
  • Identifying and executing opportunities for continuous improvement
  • Promoting awareness and understanding of the quality management system
  • Designing training resources and providing training for quality-related processes
  • Assisting QA management with other functions as required and supporting other elements of a QA system, e.g., non-conformances, process improvements, etc.
Requirements:
  • Minimum 2 years' experience in medical device internal or supplier auditing required
  • Experience with QMS within the medical device industry
  • Significant level of knowledge of the ISO standards (ISO 9001, ISO 13485, ISO 19011)
  • Auditing qualifications - Internal auditor or Lead Auditor certification
  • Strong background in auditing and quality management systems best practice
  • Ability to work well independently and as part of a team
  • Expertise in MS Office Suite
  • Bachelor's degree in a related field or equivalent work experience preferred
  • Familiarity with supplier management process
  • Experience with developing and delivering training modules
What We Offer:

We provide a supportive and dynamic work environment with opportunities for career growth and development. If you're passionate about quality and customer satisfaction, we encourage you to apply for this exciting opportunity.

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