Abbott Quality Assurance Associate in Sydney, Australia
Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
An exciting opportunity has arisen for an experienced and knowledgeable Quality Assurance Associate. Reporting to the Quality Assurance Manager, this position is responsible for supporting the Quality Management System (QMS) implementation, improvement and training, and managing the quality operations, non-conforming and monitoring processes.
The main aspects of this role include:
Develop, implement and maintain the local quality management system and ensure alignment with current and new Global Quality initiatives
Where appropriate, develop and implement additional standard operating procedures or work instructions to fulfil local Regulatory/Quality requirements or business needs
Identify and manage continuous improvement activities through the local change management system from initiation through to effectiveness
Manage the document control and record management processes
Ensure that all employees receive appropriate training and competency assessment relating to the Quality Management System using LMS as the primary tool
Develop and conduct face to face or classroom training programs on topics relating to Quality
Facilitate and assist with department owners/representatives in the development and implementation of the necessary quality related procedures and training
Develop a thorough working knowledge of ISO13485
Achieve certification as an Internal Auditor
Prepare, conduct and complete internal and supplier audits as per the local audit program
Participate in and drive the progress of Quality related projects and action plans are prepared, tracked, regularly reviewed and actioned by process owners
Identify and investigate quality issues and escalated through the CAPA system as required. Suggest corrective actions, drive implementation and effectiveness activities with those responsible for the relevant functional area
Actively look continuously to improve processes and applications
Support the preparation for corporate and external audits. Assist with audit responses, investigational activities, action plans and the implementation of actions to resolve any non-conformity identified
Support quality system deployment in all remote Abbott offices and third party warehouse providers in NZ
Ensure monitoring of distributors on quality aspects as described in the Quality/Distribution Agreement.
Execute the position and division responsibilities according to applicable Abbott ANZ Standard Operating Procedures
Perform other related functions and responsibilities as requested by the Quality Assurance Manager.
Facilitate the Supplier evaluation, approval and monitoring process and maintain the local Approval Supplier List Register
Compile periodic quality metrics, analysis and reporting as required
Complete quality inspections of all goods returning into the warehouse, determine and process the usage disposition and complete the relevant transactions in SAP
Prepare metrics related to non-conformances
Manage the quarantine area and process non-conforming product as appropriate
Provide quality support and input into the Environmental monitoring process and in relation to the Shiphold and Field Action processes
Work proactively with field staff to understand the quality requirements for product in their care
In addition to the above, the relevant experience is required:
This role will work within a team of very capable and passionate individuals committed to getting the best outcomes for the patients and the customers that we serve.
Abbott provides some fantastic benefits for our employees, these include:
Discounted Shares program
Fresh fruit available to employees
AND…..Lots, lots more
Abbott is an equal opportunity employer
We ask that recruiters respect our internal recruitment process and PSA panel, and refrain from contacting us, or referring candidates to this role.
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 firstname.lastname@example.org