QMS Coordinator

Via Incisive Technologies Pty Ltd 

Applications close 5 February 2021.

The Opportunity

Incisive Technologies is developing a novel technology which is expected to propel significant changes to how oral health care is delivered globally. We are growing, manufacturing and expecting to launch our product (called “BlueCheck”) in 2022.  We are transitioning from a virtual company to a global sales and manufacturing company and looking for clever, committed members to join our growing team. Currently, we are seeking someone to learn, then lead, our Quality Management Systems (QMS).  This role could be full- or part-time depending on the background of the successful candidate.  You will be responsible for managing the QMS activities and benefit from outstanding mentorship during the first six months from the current head of QMS who has more than 30 years of experience in quality systems and manufacturing.

The Role

Reporting to the Chief Scientific Officer, your responsibilities will include:

  • Ensure that all regulatory, statutory and corporate requirements are met
  • Management of QMS, maintaining ISO 13485 accreditation and FDA compliance
  • Plan and manage resources to ensure test results are generated in compliance with approved procedures and are available on time and in full
  • Schedule and oversight internal audits and conduct Gap Analysis of QMS
  • Manage the review, update, maintenance and completion of quality records and documentation to ensure integrity of information
  • Ensure QC assays are reviewed and validated/revalidated as required
  • Manage Corrective and Preventive Action (CAPA) and non-conformance systems
  • Manage Document Control, Change Management and SOP authorisation
  • Maintain good working relationships with key suppliers and internal/external customers
  • Provide expert information to auditors as required
  • Ensure Incisive’s health and safety procedures and business policies are followed

Skills and Experience

The successful candidate must have:

  • BSc or relevant scientific (STEM) tertiary qualification, preferably in Biological Sciences or related discipline
  • Previous experience in a quality management related role, or similar, within a highly regulated sector such as bio-medical/tech or pharmaceutical
  • Experience in an ISO accredited environment, preferably 13485:2016 (or 21CFR820).
  • Demonstrated ability to manage a busy work environment, whilst delivering on quality and business priorities
  • Able to capture and process complex data, through the use of Excel or similar, to display and report findings
  • Excellent communication and interpersonal skills
  • Some knowledge of cGMP regulations and Quality Management Systems
  • Strong problem-solving skills and organisational skills

Other useful attributes include:

  • Sound analytical skills and able to communicate complex matters to a range of audiences
  • Experience in a high-paced manufacturing environment; clean room experience is a plus
  • Experience in working with a team to drive improvements and efficiency gains
  • Experience in developing and delivering training programs
  • Experience with eQMS (ACE) software

Decision Making Levels

  • Develops, authorises and implements quality procedures, change/document requests and revisions for the efficient running of QMS
  • Determines how to meet senior management directives through the design and delivery of training programs
  • Recommends business change in relation to quality and compliance/accreditation
  • Recommends future human and equipment resource management to improve the business 

Ideal Behaviours

  • Explore needs, concerns and positions of others
  • Identify points of agreement and disagreement
  • Present alternatives
  • Keep arguments issue-oriented
  • Reach agreement through compromise
  • Seek a win-win solution

Other selection criteria

  • Current and valid driver’s licence, or access to sufficient transport
  • Able to travel nationally and internationally for work on occasion
  • Able to work flexible hours to meet business requirements 

How to apply

Whilst QMS processes and policies are in place, this role provides a substantive opportunity for the right person to place their stamp on a critical area essential to Incisive’s success.  You will be working with experienced, thoughtful and honest people.  If you are looking to be part of an exceptional team, develop new skills and shape a new future in oral health care, we ask you to apply.  Applications close 5 February 2021.

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