QA Manager

Abbott


Date: 22 hours ago
City: Sydney, New South Wales
Contract type: Full time
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.
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