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

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com