Benefits
Gain exposure in both medical device and pharmaceutical operational activities whilst working in a company with a positive team culture.

About the Company
With over 30 years’ experience in research and design, this South Sydney based medical device company brings an innovative and niche product to the healthcare industry. The company is driven by enhancing and developing medical innovations for diagnostic imaging, specialising in lung health. This is an exciting time to join the organisation as they embark on obtaining new market share and enhancements of their products.

About the Opportunity
You will review the utilisation of personnel, equipment, materials, and processes. This will facilitate the continuous improvement of operations. You will be ensuring documentation is compliant with the ISO 13485 QMS and relevant regulatory requirements.

Duties

• Support and coordinate the implementation of engineering systems / processes
• Ensure all engineering related activity documentation is compliant with regulatory requirements and the QMS
• Participate in risk assessments and validation activities on production processes
• Revise and adhere to SOPs, Device History Records (DHRs) and Forms (FRMs) as required
• Manage Change Controls and investigate non-conformances in relation to the Operations Team
• Participate in complaint investigations as required.


Skills and Experience

• University qualification in Science, Engineering, or relevant discipline
• Experience working in an ISO13485 certified environment
• Knowledge of validating systems or processes would be preferred
• Must have experience in a similar role within medical device or pharmaceutical manufacturing environment in either Operations or Quality Assurance

Culture
Collaborative team environment. This organization values integrity, innovation, and quality whilst manufacturing and developing innovative technologies.

How to Apply
Click apply or contact Tamara El Husseini, Sourcing Consultant on 0288778775 for a confidential discussion.