Quality & Compliance Manager

Quality & Compliance Manager

Aruma | lambton, NSW, AU

Posted 10 days ago

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Description

Location:

Lambton/Burleigh
  • Full Time Perm / 38 hours per week
  • Your responsibilities

  • Develop, implement, and maintain the Quality Management System for Medical and Forensics operations.
  • Warrant that the high quality of Medical Packs and Supplies (MPS) and Forensics products through quality control of raw materials, suppliers, and production processes.
  • Safeguard new and existing MPS and Forensics products met the relevant regulatory requirements, and standards including ISO13485, and ISO18385.
  • Assist in and conducts internal audits, collaborating with Quality, Safety and Risk Officer and Quality Assurance Supervisor & Officer as required.
  • Liaise with TGA representatives, administrator and maintains product registrations on TGA website.
  • About you

  • A relevant tertiary qualification and a minimum of 5 years’ experience working in quality management in a similar industry.
  • Experience working within a TGA regulated environment particularly ISO 13485 (medical devices), ISO 18385 (forensics), ISO 11135 (EO healthcare products), ISO 11737 (micro methods), ISO 11137 (gamma sterilisation), and TGA standards.
  • Sound analytical and problem-solving, experience with data reporting on Quality and Production outcomes and trends, incident reporting via Periscope and Scout whilst managing continuous feedback, or complaints.
  • Sound numeracy and computer skills (MS Office), including the capacity to learn new IT systems.
  • NDIS Worker Screening Check or willing to obtain
  • A confirmation record of COVID-19 vaccination in accordance with state legislation
  • A current driver’s licence, or the availability to travel across relent Aruma locations
  • What we offer

  • A dedicated team, ongoing support, training, and development.
  • As a charitable organisation, our staff benefit from some Fringe Benefit Tax exemptions through salary packaging up to $15,900 p.a + up to $2,650 p.a on meal & entertainment.
  • Salary package living expenses (, mortgage, loan, credit card repayments) meal and entertainment (dining out), vehicle (new or used).
  • We offer employees and their immediate family members access to a confidential, impartial, and professional counselling service.
  • Corporate health plans with Bupa.
  • Fitness Passport.
  • Diversity & Inclusion

    Aruma is a Child Safe Organisation and an Equal Employment Opportunity (EEO) Employer. To this end, we invite applicants to answer optional questions around Diversity and Inclusion as part of the recruitment process. The information provided will be treated in strictest confidence in accordance with Aruma’s Privacy Policy.

    Culture

    People love to work at Aruma because they get the satisfaction of knowing they are Supporting people to live a great life, the life they want, the way they choose. Aruma is also BRAVE. That's what makes us a trailblazer, being part of our team means you need to meet our BRAVE behaviours (Bold, Respectful, Authentic, Value Teamwork, Excellent) Find out more at

    Only applicants with the right to work in Australia will be considered. Shortlisted applications will be required to undergo pre-employment probity checks.