PRIMARY OBJECTIVE:
Responsible for maintaining the Quality Management system and ensuring compliance with applicable Corporate, Divisional, and local regulations.

CORE JOB RESPONSIBILITIES:

Support quality and post-market regulatory compliance across Abbott Vascular products and services in Australia and New Zealand.

Assist in continuous improvement opportunities within the affiliate quality management system.

Ensure compliance with ISO9001 certified Quality Management System (QMS) and support post-market regulatory requirements and key internal divisional quality-related policies and procedures.

Assist in developing, implementing, and monitoring Quality and Regulatory Compliance strategies for the affiliate.

Support evaluation of systems, operations, and practices against regulations and company documentation.

Manage document control for QMS procedures and quality records.

Assign QMS training to employees in LMS (Learning Management System).

Provide inputs for monthly KPI data and affiliate updates for regional management review meetings.

Identify major quality compliance risks and threats to the overall business in the ANZ region and update management.

Prepare and support Internal & External Quality & Compliance Audits.

Maintain a risk management program associated with the elements of the quality system.

Maintain quality system certification in compliance with ISO9001 and support transition processes during standard revision.

Support remediation plans for external, internal, and supplier audits through the CAPA process.

Execute Product Stop Shipment and Field Safety Corrective Actions as per instructions from Regional QA.

Interact periodically with Commercial, Regulatory Affairs, Supply Chain, Technical Service, Education, and other functions on quality-related matters.

Work cohesively with all functions at local and regional levels on requirements for Quality and Regulatory Compliance.

Maintain up-to-date knowledge of Abbott procedures and local regulations.

Provide training to affiliate teams as needed.

Post Market Complaint Handling:

Oversee product experience/complaint events within the Complaint Handling System.

Adverse Event Reporting:

Oversee the coordination of answers to TGA and Medsafe follow-up Device Incident Reports and questions.

OTHER FUNCTIONS AND RESPONSIBILITIES:

Perform various administrative functions as required.

Any other activities as assigned by the Line Manager.

EDUCATION/QUALIFICATIONS/EXPERIENCE:

Minimum of a bachelor’s degree in Science/Pharmacy/Engineering or equivalent/relevant education/work experience in Medical Devices or Pharmaceutical industry.

Computer proficiency in Word, Excel, and PowerPoint.

Strong interpersonal skills, with the ability to build and maintain relationships.

Effective time management - well organized, able to set and reset priorities.

Strong oral and written English communication skills.

Detail and deadline oriented.

Ability to work in a fast-paced, multi-tasked environment.

Positive attitude towards risk, change, and unexpected challenges.

Team-oriented, cooperative, and agreeable.

EXPERIENCE REQUIRED:

About 7-10 years of work experience in a Commercial Quality Organization in Medical Device or Pharmaceutical organization.

Good understanding of medical device regulations in Australia & New Zealand.