Our client is a world-class IVD organisation, delivering innovative and advanced healthcare solutions to address unmet needs and save lives.
Reporting to the Operations Manager, the Quality and Process Engineer will serve as a pivotal member of the technical team and support the transfer to production of new products.
The Quality and Process Engineer will be responsible for supporting the Australian day-to-day manufacturing by troubleshooting process and raw material arising issue that impede with production yield, throughput and product performances. In addition, the Quality and Process Engineer will be responsible for maintaining the Australian processes in a validate state through a flawless execution and maintenance of the validation master plan in compliance with ISO 13485, 21 CFR 820, and Clinical Genomics QMS.
Very strong analytical skills, organisational skills and attention to details are key to success in this position. Sound understanding of IVD manufacturing requirements (GMP, GLP, Process Validations, IQ/OQ.PQ, D/PFMEAs), strong understanding of mechanical engineering concept (kinematic, dynamic, fluid mechanics,…) and a good understanding of applied statistics is a must. Finally, Excellent communication and planning skills, combined with experience working in a small but fast paced team are essential. Interpersonal skills, accountability and responsiveness are key attributes for the right candidate.
The Successful will possess:
• 5-10yrs experience in the medical device industry, preferably IVD, in a production or process position with a strong focus on documentation
• Strong experience in process troubleshooting and root cause analysis with deep knowledge of root-cause analysis methods.
• Preferably leadership experience of risk management activities.
• High-level technical writing skills and documentation experience including: protocol design, execution and reporting; use of root cause analysis techniques
• Multiple hands-on experiences with process validation IQ/OQ/PQ, including packaging, labelling, and DMR writing
• Sound knowledge of GMP, ISO13485, 21CFR 820, Design Controls
• Sound knowledge of process development and validation,
• Understanding of lean manufacturing, six sigma concept
• Knowledge or familiarity with molecular biology, specifically Immuno-Chemistry is preferred.
For a confidential discussion, please contact Sonal on 0411 499 207 or Lucia on 0410 56 56 26. Alternatively, please submit your application to firstname.lastname@example.org.
Kindly note that only shortlisted candidates will be contacted – Thank you for your interest and consideration!
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