Quality Assurance / Regulatory Affairs Officer

The Company: 

Parker Healthcare Pty Ltd is a successful Australian owned and operated Quality Assured ISO 9001 medical supplies company that has provided innovative medical solutions to hospitals for over 35 years. 

Parker Healthcare’s products cover six trade divisions being hospital, home healthcare, aged care, pharmacy, dental and veterinary.   Our hospital division has a strong market presence throughout Australia and New Zealand representing a number of leading brands including the Atom range of Infant Care Incubators and Infant Warmers.  Other products within our range include oxygen therapy consumables, resuscitation circuits, analgesic circuits, thermometers and a broad range of specialized infant care products. We also have a manufacturing facility in Malaysia, and the QA / Regulatory Affairs Officer may have the opportunity to support their QA team. 

The Position:

We are seeking an experienced QA  / Regulatory Affairs Officer to be based at our Mitcham Head Office. This position is casual, for approximately 15-30 hours per week, depending on role demands.

Duties of this role will include:

• Maintain, update and control Quality Assurance Documentation
• Ensure company compliance with Quality Assurance ISO9001
• Complete internal and external audits and Quality Risk Assessments
• Ensure quality systems are operational and compliant
• Liaise and make various submissions with national regulatory affair authorities
• Assist Malaysian manufacturing plant as required  with ad hoc Regulatory Affairs, technical files and QA compliance

To be successful in this role you shall have:

• Minimum of 2 years' experience in a Quality Assurance / Regulatory Affairs role 
• Previous experience in medical device applications with TGA is an advantage
• Experience and understanding of Quality  Management System ISO 9001
• Experience in conducting internal audits, Quality Risk Assessments and handling external audits
• Exceptional organisational skills and ability to meet deadlines
• Ability to work autonomously
• Strong communication skills
• Ability to solve problems
• Strong computer skills (Microsoft Office)
• Full Australian working rights