Responsibilties:

• Responsible for processing, investigation, classification and trending of customer feedback
• Ensures that all customer feedback is properly investigated in accordance with procedures and FDA/ISO requirements
• Provides  timely and satisfactory response to customer feedback
• Liaises with Supply Chain , R&D and other groups to determine identify root cause and solve issues for the customer
• Experimental design and/or performance of hands-on laboratory studies to aid in problem resolution
• Communication of problem resolutions and/or investigation outcomes to all appropriate personnel
• Ensures that confirmed issues or reportable events are escalated to the appropriate personnel in a timely manner.
• Issue of clear reports concerning investigations to internal and external groups
• Ensures CF reports are compliant from a regulatory stance

Education/Experience:

• Will hold a B.Sc., M.Sc., or PhD in chemistry, biochemistry, biology or other relevant technical field.
• 2+ years experience within a QA role with a healthcare environment
• Applicants must be available for a 12 month contract role
• Strong interpersonal and communication skills are an essential prerequisite with the ability to influence.
• Must have significant experience in a Quality role, within an FDA regulated industry. 

For additional information please contact Melissa Foley at Harmonics on 061 336136