- Established Leading Australian Owned Manufacturer
- Help establish a new QMS
- Be part of providing PPE to our healthcare workers
About our Organisation
Detmold Medical has recently been established as a result of a partnership with the State and Federal Governments to manufacture medical masks (PPE). Detmold Medical has set up a new manufacturing facility to ensure supplies for our primary health care workers. Detmold Medical is part of the Detmold Group which is an Australian owned and operated business.
About our Opportunity
A new 12-month full time contract opportunity reporting to the Quality Manager has been created for and an experienced quality assurance professional who has strong attention to detail and has worked in a production environment. To be successful in this role you will also need excellent written and verbal communication, first rate organisational skills and an enthusiastic and constructive approach in engaging with others.
Your key responsibilities will include:
- Assist in implementation and maintenance of the Quality Management System to ensure compliance with ISO13485 and TGA requirements for medical devices.
- Document control and records management
- Conduct and assist with internal audits.
- Conduct and assist with delivery of QMS training.
- Assist with implantation of CAPA.
- Managing site registers including Document Control, Non-Conformance, Corrective and Preventive Actions, Change Control, Risk Management, Critical Material Inspections, Product Testing Register.
- Proofread and revise documents such as procedures and specifications
- Promote awareness of GMP and QMS requirements withing the company.
Ideally you will have:
- Experience in quality assurance within GMP environment (medical devices or similar regulated environment is highly desirable)
- Practical internal audit experience, with certification would be an advantage.
- Relevant tertiary qualifications
- Experience driving a quality system within an organisation.
- Experience using the MS Office Suite particularly MS Word, PowerPoint with advanced MS Excel skills.
To apply for this position please submit your cover letter. To learn more about our organisation please visit our website at www.detmoldgroup.com.