Quality Assurance Manager

6 days ago

Sydney, New South Wales, Australia beBeeQuality Full time
Quality Assurance Professional

Join us in this exciting opportunity to lead and support quality management processes and teams.

The successful candidate will have a strong background in quality assurance, with experience in championing quality within an organisation and monitoring, maintaining and improving the Quality Management System (QMS) in accordance with ISO 13485 and ISO 9001 standards.

  • Champion quality within the organisation, towards fulfilling our corporate mission
  • Monitor, maintain and improve the QMS in accordance with ISO 13485 and ISO 9001 standards
  • Ensure overall compliance to standard operating procedures in line with the QMS
  • Develop audit programs and plans, perform internal audits and co-ordinate external audits
  • Identify, plan and document opportunities for improvement in company processes and systems and work with subject matter experts to drive implementation
  • Manage and process CAPA related activities
  • Identify and advise on relevant standards and regulation for product developments, maintain up to date libraries of applicable standards and regulation across global markets
  • Facilitate company and product development risk management in accordance with best practices, including ISO 14971, IEC 60812 and ISO 31000
  • Facilitate appropriate identification and records of product user needs, requirements verification and validation activities and traceability throughout development
  • Manage quality for the development of medical devices according to regulation such as CE MDR, FDA and TGA and standards including ISO 13485, IEC 60601 and IEC 62304
  • Manage the calibration of test and measurement equipment
  • Select and evaluate suppliers, monitor quality agreements, and manage actions arising from goods inspection
  • Develop and conduct induction and training on QMS processes and policies, and promote QMS regulatory requirements to all staff

The ideal candidate will have:

  • A relevant qualification from a reputable education organisation
  • At least 5 years' experience in quality management or a similar role
  • In-depth knowledge of ISO 13485 and ISO 9001, as well as regulatory requirements pertaining to product development
  • Understanding of a variety of production/manufacturing processes
  • Experience in communicating with and evaluating local and offshore suppliers
  • Excellent verbal and written English communication skills
  • Ability to work independently and as part of a team

Preferred skills and qualifications include:

  • ISO 17955 Lead Auditor certified
  • Quality management experience in product design and development

Why join us?

We are one of Australia's leading product design teams, providing comprehensive design services to leading Australian and international companies. Our team spans industrial and mechanical design, electronics, embedded, iOS, Android, Linux app, web servers and more. We offer a unique opportunity for creative, passionate, professional designers and engineers to continue to develop their skills with us.

Our Sydney office is located in the North Ryde technology area with convenient access by road and public transport. We provide workplace flexibility by allowing staff to work from home for part of the week.

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