Senior Auditor Medical

The professional staff member shares in the responsibility to further company growth and profitability. Under limited general supervision, he/she audits customers’ quality systems, as well as develop the business to further expand medical services in the Australian market place.

This position requires specialized knowledge and consistent exercise of discretion and judgment. This position assists with the training and coaching of Auditors and Lead Auditors to support their development.

About the Job

Job title: Senior Auditor/Manager
Reports to: General Manager, Products
Dept./Division: Medical

Job Duties/Resposibilities

  • Maintain client relations, be the point of contact for Medical clients.
  • Authorized to lead an audit team and responsible for timely and successful accomplishment of the assigned project.
  • Complies with the policies of TRAUS and follows the procedures of the Certification Body.
  • Authorized to prepare, perform and document pre-audits, registration audits, re-audits and surveillance audits following relevant published standard(s), regulatory requirements and company procedures.
  • Applies sound judgment and analytical skills in order to obtain and assess objective evidence fairly, remains true to purpose of audit without fear or favor, evaluates constantly the effects of audit observations and personal interactions during audit, commits full attention and support to the audit process, reacts effectively in stressful situations, arrives at generally acceptable conclusions based on audit observations, and is not to be influenced by undue pressure.
  • Applies technical expertise in medical technology discipline to evaluate technical aspects of auditee's system.
  • Maintains his/her competence by insuring that his/her knowledge of quality systems and auditing procedures is current; takes additional and/or refresher course(s) if and when necessary.
  • Is subject to annual performance evaluations as well as periodic observation during audit. / Communicates with customers regarding interpretation of relevant standards and regulatory requirements. / Strives to acquire new customer business when applicable and supports the Sales Organization.
  • Performs other related duties and assignments as necessary. / Supports the internal qualification of new and existing employees through providing internal training, feedback and coaching regarding audit and technical performance.
  • Maintains product specific expertise in several product categories.

Requirements

Education and Training

  • Minimum Bachelor’s Degree in Engineering or any natural science, with concentration in medical technology
  • Technical expertise in the medical product field achieved through education or work experience
  • Knowledge and understanding of the standards and regulatory requirements against which audits may be performed
  • Knowledge and assessment techniques (examining, questioning, evaluating and reporting)
  • Management capabilities (planning, organizing and directing)

Experience / Qualifications

  • Minimum four years full-time appropriate practical workplace experience, at least two of which should have been in quality assurance activities
  • Qualified Lead Auditor for a Registrar or Notified Body
  • Two years Supervisory and/or managerial experience
  • Experience in the entire audit process per ISO 19011 / ISO 17021
  • Deep knowledge and practical experience in MDD/IVD/AIMD Devices and Directives

Personal Attributes

  • Open-mindedness, patience and maturity
  • Sound judgment, analytical skills and tenacity
  • Understands complex operations from a broad perspective
  • Able to work independently as well as part of a team

Contact information

Please use the apply button to submit your application or write to

TÜV Rheinland Australia Pty. Ltd.
Attn: Personnel Department
PO Box 5050
Heidelberg West VIC 3081
Australia

*We handle all applications confidentially. CVs / resumes are not returned.