QA Coordinator

JOB DESCRIPTION:

Primary Job Function

• To ensure timely processing of product returns to the manufacturer, this includes physically processing the product returns from the field and sending to manufacturer for product investigation as part of our product experience reporting requirements. Ensure relevant implantable devices are traceable through the Abbott Medical Australia & New Zealand (ANZ) Patient Device Tracking (PDT) database and process. 
• To ensure compliance of the PDT process in accordance with TGA Requirements. 
• The role is responsible for communication with field personnel, hospitals and patients regarding patient implant information and card issuance.

Core Job Responsibilities

• Timely processing of product return shipments, including international shipments.
• Cross functional communication and interaction with various functions including regulatory, customer service, supply chain, etc. and others as required.
• Process stock transfers and material requests associated with complaint device management.
• Process all relevant implantable product/patient details for CRM, NMD, SH and HF Business Units. This would include entering all new information as well as any changes to patient or product information. This also includes calls from patients, hospitals and/or clinics. 
• Perform weekly patient implant registration duties such as  card printing and mailout within agreed turnaround timelines.
• Supporting the PDT training for new employees.
• Assist in managing customer calls and enquiries post-implant associated with PDT.
• Assist with sales data management; implant tracking, working with spreadsheets to provide data for sales staff.
• Support customer complaints according to Abbott ANZ Field Event Reporting Standard Operating Procedure.
• Knowledge of and commitment to the requirements of the Quality Management System.
• Knowledge of and commitment to Work, Health & Safety responsibilities.
• Execute the position and Business Unit responsibilities according to applicable Abbott ANZ Standard Operating Procedures.
• Perform other related functions and responsibilities as directed by Manager.
• Assist with Quality Objectives for maintaining ANZ Quality System and ensuring continuous improvement.
• Processing demonstration stock requests as per procedure requirements.
• Contribute to the review of key performance indicators and metric escalation.

Minimum Experience/Training Required

• Previous experience in a similar role, preferably in a medical devices / pharmaceutical environment.
• Proficient at using Microsoft Office Suites (ie. Word, Excel & PowerPoint). Experience with SAP is advantageous.
• Understanding of industry standards and regulations such as the TGA patient information guidelines, MTAA Code of Conduct & Abbott / SJM HCP Code of Conduct.

Note:  This job description describes the principal and main elements of the job. It is a guide to the nature and main duties of the job as they currently exist, but is not intended as a wholly comprehensive or permanent schedule and is not part of the contract of employment.

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:
Operations QualityDIVISION:
EP ElectrophysiologyLOCATION:
Australia > Macquarie Park : 299 Lane Cove RoadADDITIONAL LOCATIONS:
WORK SHIFT:
StandardTRAVEL:
Not specifiedMEDICAL SURVEILLANCE:
Not ApplicableSIGNIFICANT WORK ACTIVITIES:
Not Applicable