Abbott Senior 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 enthusiastic Senior Quality Assurance Associate. Reporting to the Senior Technical Services Manager, this position is responsible for managing all aspects associated with quality of customer feedback associated with Abbott Nutrition products and services supplied in Australia and New Zealand.
The main aspects of this role include:
Provide support to post-Market Surveillance/Vigilance reporting activities for Australia and New Zealand and service related customer feedback
Support the continuous improvement activities and continued compliance to ISO9001 certified Quality System, applicable post market regulatory requirements and key internal divisional quality related policies and procedures
Implement the divisional quality system elements for the ANZ business
Maintain the quality system to the applicable regulatory requirements in ANZ
Manage Field Correction Safety Actions in ANZ and report to Regional Coordinator
Manage the internal audit program and follow up on any subsequent action items
Facilitate any external audits as required
Manage the exception process (CAPA) for the affiliate
Coordinate the Record Retention Policy for ANZ
Manage the documentation management system and coordinate the training associated with the Quality System policies and procedures
Coordinate the management review meetings as the management representative
Establish a risk management program associated with the elements of the quality system
Champion continuous improvement opportunities within the quality management system
Oversee product experience/complaint events within Complaint Handling System (Trackwise)
Ensure product experiences are submitted in a timely manner and all follow up questions addressed within specified timelines
Track, trend and monitor all ANZ product experiences
Produce monthly reports to management team for product experience key performance indicators (KPIs)
Manage all ANZ product experiences to closure including customer communication
Manage internal training for Product Experience Handling Process
Maintain a quality system in compliance to ISO9001:2008 and transition to ISO9001:2015
In addition to the above, the relevant experience is required:
Advanced computer skills with proficiency with Microsoft applications (Word, Excel, Visio) and Adobe Professional
Analytical, detail oriented
Excellent organizing, planning, verbal and written skills.
Excellent presentations skills
Strong interpersonal skills, with the ability to build and maintain relationships
Comfortable in a matrix environment and interfacing with different international sites / Singapore and US business units
Science Degree or 5 years experience in an equivalent role
Experience of ISO9001 Quality Management Systems and experience implementing continuous improvement projects within quality systems is essential
Strong Auditing background is essential
Previous experience in adverse event reporting to competent authorities is desirable
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