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

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.

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.