Senior Process Engineer

Responsibilities: 

Drive investigate and review the utilisation of personnel, equipment and materials, operational processes, and established practices, to facilitate improvement in the efficiency of operations. In addition, ensure that associated documentation is in compliance with Quality Management Systems (QMS) and relevant regulatory requirements.

Main Duties:

• Lead the review of completed assemblies and documentation of TechnegasPlus Generator (TP) Manufacture to ensure compliance with QMS and relevant regulatory requirements.
• Provide subject matter expert review of PAS processes and documentation to ensure compliance with QMS and relevant regulatory requirements.
• Provide subject matter expert review of crucible manufacture and packaging processes and documentation to ensure compliance with QMS and relevant regulatory requirements.
• Lead and co-ordinate and/or participate in risk assessments on production processes.
• Develop, revise and maintain Operation's Standard Operating Procedures (SOPs), Device History Records (DHRs) and Forms (FRMs) as required.
• Raise and manage Change Controls and investigate Non-Conformances for the Operations Team.
• Participate in complaint investigations as required.

Qualifications & Experience: 

University Degree in Science, Engineering or equivalent. Minimum 4 years’ of experience in a medical device and/or pharmaceutical industry working in either Operations or Quality Department.

• Flexible hours available
• More than 4 years of relevant work experience required for this role
• Work visa can be provided for this role
• Expected start date for role: 20 May 2024
• Expected salary: $120,000 per year