**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.