Senior Qa Specialist

The incumbent will actively support the quality efforts of Australia & New Zealand as part of the organization's business objectives, reporting directly to the in-country Quality Manager. The role is responsible for the management and monitoring of critical quality process performance acting from a subject matter expert perspective, ensuring continued compliance to internal quality requirements and standard. This will be achieved thought compliance to internal procedural requirements, and the development and implementation of additional SOPs, work instructions, checklist etc., where applicable. This role is responsible for the monitoring of compliance, the communication of procedural requirements, training on quality system requirements and supporting corrective actions where applicable.
KEY RESPONSIBILITIES:Play a major role in the facilitation of the communication of adverse events to the Regulator.
When quality gaps are identified, and Corrective and Preventive Actions (CAPA) are required, lead investigations & root cause analysis, supporting the development & implementation of appropriate corrective actions.
Act as the main Document control and training admin for the local quality system.
Support the evaluation & quality management of internal & external suppliers. Assist QA Manager ANZ to manage the internal auditing program.
Play a major role in the tracking and trending of quality departmental key performance indicators, to allow efficient oversight of the local quality system.
Establish effective partnerships within the business locations to ensure QA needs are identified and successfully met.
Build effective relationships with local departmental representatives, Regulatory body representative & Global counterparts.
REQUIRED EXPERIENCE AND BACKGROUND:3+ years in a QA Role within the Medical device, Pharmaceutical or related industry experience.
Experience in the handling of adverse event for reporting purposes and corrective & preventative action problem-solving methodologies, including root cause analysis.
Ability to develop procedures and policies that clearly define efficient processes needed to ensure compliance and resolve identified problem.
Knowledge of change management & risk assessment and ISO 9001 is preferred.
Experience in leading and participating in cross-functional teams tasked with QA problem resolution.
Experience in training curriculum development and external supplier quality management is preferred.
Knowledge of internal audit program management.
Proficiency in Microsoft Office software (i.e., Word, Excel, and PowerPoint).
Abbott provides some fantastic benefits for our employees, these include: Free Parking
Flexible working options
Leading Training and development programs
Discounted Healthcare
Discounted Shares program
Wellness program that includes Fresh fruit etc.
Easy access to public transport, bus and rail
Abbott provides some fantastic benefits for our employees, these include: Leading Learning and Development opportunities
Wellness programs
Discounted share options
Being part of an organisation reputed to be a World's Top Employer recognised for our workplace culture that values healthy living, diversity and equal opportunity
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries. Abbott is committed to building a diverse workforce that values diversity across gender, age, culture, disability and lifestyle.
In order to be eligible to work for Abbott in Australia or New Zealand, you must hold current working rights with no restrictions for the respective country applicable.
We ask that recruiters respect our internal recruitment process and PSA panel by refraining from contacting us or forwarding unsolicited profiles.
The base pay for this position is
N/A JOB DESCRIPTION:About the Opportunity:The incumbent will actively support the quality efforts of Australia & New Zealand as part of the organization's business objectives, reporting directly to the in-country Quality Manager. The role is responsible for the management and monitoring of critical quality process performance acting from a subject matter expert perspective, ensuring continued compliance to internal quality requirements and standard. This will be achieved thought compliance to internal procedural requirements, and the development and implementation of additional SOPs, work instructions, checklist etc., where applicable. This role is responsible for the monitoring of compliance, the communication of procedural requirements, training on quality system requirements and supporting corrective actions where applicable.
KEY RESPONSIBILITIES:Play a major role in the facilitation of the communication of adverse events to the Regulator.
When quality gaps are identified, and Corrective and Preventive Actions (CAPA) are required, lead investigations & root cause analysis, supporting the development & implementation of appropriate corrective actions.
Act as the main Document control and training admin for the local quality system.
Support the evaluation & quality management of internal & external suppliers. Assist QA Manager ANZ to manage the internal auditing program.
Play a major role in the tracking and trending of quality departmental key performance indicators, to allow efficient oversight of the local quality system.
Establish effective partnerships within the business locations to ensure QA needs are identified and successfully met.
Build effective relationships with local departmental representatives, Regulatory body representative & Global counterparts.
REQUIRED EXPERIENCE AND BACKGROUND:3+ years in a QA Role within the Medical device, Pharmaceutical or related industry experience.
Experience in the handling of adverse event for reporting purposes and corrective & preventative action problem-solving methodologies, including root cause analysis.
Ability to develop procedures and policies that clearly define efficient processes needed to ensure compliance and resolve identified problem.
Experience in document control & training management.
Knowledge of change management & risk assessment and ISO 9001 is preferred.
Experience in leading and participating in cross-functional teams tasked with QA problem resolution.
Experience in training curriculum development and external supplier quality management is preferred.
Knowledge of internal audit program management.
Proficiency in Microsoft Office software (i.e., Word, Excel, and PowerPoint).
Abbott provides some fantastic benefits for our employees, these include: Free Parking
Flexible working options
Leading Training and development programs
Discounted Healthcare
Discounted Shares program
Wellness program that includes Fresh fruit etc.
Easy access to public transport, bus and rail
AND…..Lots, lots more
Abbott provides some fantastic benefits for our employees, these include: Leading Learning and Development opportunities
Wellness programs
Discounted share options
Being part of an organisation reputed to be a World's Top Employer recognised for our workplace culture that values healthy living, diversity and equal opportunity
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries. Abbott is committed to building a diverse workforce that values diversity across gender, age, culture, disability and lifestyle.
In order to be eligible to work for Abbott in Australia or New Zealand, you must hold current working rights with no restrictions for the respective country applicable.
We ask that recruiters respect our internal recruitment process and PSA panel by refraining from contacting us or forwarding unsolicited profiles.
The base pay for this position is
N/A In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Operations QualityDIVISION:ADC Diabetes CareLOCATION:Australia > Macquarie Park : 299 Lane Cove RoadADDITIONAL LOCATIONS:WORK SHIFT:StandardTRAVEL:Not specifiedMEDICAL SURVEILLANCE:Not ApplicableSIGNIFICANT WORK ACTIVITIES:Not Applicable
About Us Abbott  is about the power of health. For more than 135 years, Abbott  has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it's next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.
The people of  Abbott  come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life's greatest health challenges.
We invite you to explore opportunities at  Abbott , to see if your talents and career aspirations may fit with our openings. An equal opportunity employer,  Abbott  welcomes and encourages diversity in our workforce.
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