We have an exciting opportunity for a Quality Assurance Manager for Abbott Medical, reporting to the Quality Director, ANZ.

Role Summary:

• Manage and develop the local ANZ Quality System to ensure alignment and compliance to Abbott internal requirements.

• Manage and develop the ANZ Quality Management System to ensure ongoing ISO9001 certification.

• Manage and implement systems and process controls to ensure the appropriate storage, handling and distribution of Abbott Medical products.

• Audit support lead for external audits and Abbott Corporate Commercial audits.

• Effectively communicate a Quality focused mindset across the commercial organisation and champion quality initiatives for ANZ.

• Support Abbott Medical’s compliance to post market regulations from the Australian TGA and New Zealand Medsafe.

Responsibilities

Manage and Develop ANZ Quality Management System

• Implement, maintain and develop the ANZ Quality Management System (QMS) and ensure alignment with the Global Commercial QMS (GCQ); the cross divisional One Abbott Commercial Affiliate (OACA); Abbott corporate quality (AQ) and local regulatory requirements

• Participate actively in the GCQ global projects and workstreams

• Focus on continuous improvement of quality processes and customer satisfaction and where appropriate update SOPs accordingly

• Manage documentation control

• Identify and investigate quality issues through the Customer Feedback/SCAR/CAPA processes, suggest and implement corrective actions.

• Propose preventive actions to avoid problems

• Maintain certification of the ANZ operation to ISO9001

• Conduct internal audits of the implementation of the quality system, facilitate corporate quality audits and quarterly management reviews with senior management

• Manage all quality system suppliers and distributors for evaluation, performance review and re-evaluation

• Ensure training of distributors/third party warehouses is completed on quality aspects described in their contract

• Participate in ship hold process and damaged or non-compliant product to ensure materials are quarantined and dispositioned appropriately

• Support post market regulatory compliance (as applicable) in areas such as adverse event reporting, post market reviews, annual reporting and field actions

• Coordinate non-product software and computer systems validation activities, as well as spreadsheet verifications/validations where required

​Effectively communicate a Quality Mindset

• Effectively communicate a positive Quality focused mindset across the organisation making the QMS relevant to each role including key performance indicators

• Develop engaging training materials, ensure employees receive appropriate training assignments via established learning plans, and ensure the QMS is deployed consistently

Post Market Regulation Support (as required)

• Ensure field action team members are trained and understand their role and responsibilities in advance.

• Assist the QA Director to implement FSCA according to instructions provide

• Maintain records of all activities, tracking list, translated DDL, reconciliation reports, acknowledgment forms etc. and upload to Record Inventory Management System (RIMS)

• Support specific requests with regards to TGA Post Market Reviews (PMR)

• Coordinate and submit annual reports

• Submit Consent to Supply requests (if required) as part a field action

Professional Knowledge, Skills & Qualifications

Industry Experience

• Previous experience in a similar role within a medical device or pharmaceutical organisation is preferred

Qualifications

• Tertiary level qualifications in a technical/scientific or related discipline