The incumbent leads the quality efforts of Australia and New Zealand in support of the organization's business objectives. The role is responsible for development, training, implementation, and monitoring of quality systems for ADC Australia and New Zealand organization and working with APAC area as well as division commercial QA organization to ensure full compliance with all laws, regulations, policies, and standards. This is achieved through assuring compliance with existing SOPs, and the development and implementation of additional local SOPs, work instructions, checklists etc., where required. This role is responsible for communication of procedural requirements, training on quality systems requirements and procedures for all affected associates, tracking compliance and the coordination of corrective measures where required.MAIN / MAJOR RESPONSIBILITIESEstablish and aggressively drive the Quality Assurance strategy for Australia and New Zealand by taking ownership and aligning with key Global ADC Quality strategies and direction.Ensure consistent application of relevant Quality Assurance policies, programs, and systems by clearly defining specific Abbott and Abbott Diabetes Care SOPs and locally developed procedures that govern critical to success business functions. Recognition that some degree of flexibility to execute activities appropriate to local requirements and market needs is also required.Elevate issues or significant events (product performance issues) to the appropriate facility with relevant facts and details enough to allow Subject Matter Experts responsible for the product quality and performance to analyze, investigate and provide feedback and corrective actions appropriate to the issue.When quality gaps are identified, and Corrective and Preventive Actions (CAPA) are required, formulate detailed action plans that integrate identified stakeholders, the actions necessary and the required methods and timelines to successfully correct the problem and prevent the issue from recurring / occurring. Ensure CAPAs identified during audits or other means are successfully resolved prior to committed due dates.Work within Australia and New Zealand to lead in audit responses and appropriate corrective actions. Review internal and external audits and respond in to assure any similar deficiencies are also addressed.Sustain ISO9001 certification for Australia.Establish effective partnerships within the business locations to ensure QA needs are identified and successfully met. Respond to manufacturing site requests (e.g., quality holds, reworks, complaint product returns).Organize and develop timely action plans in close coordination with the Regional Customer Service Manager ensuring a seamless execution of successful QA strategies for Australia and New Zealand.Develop and maintain a QA status report covering routine department functions and providing updates on key problem resolution initiatives. Examples may include status of safety alerts, quality holds, field actions (recalls), and CAPAs. The status report will include current projected completion dates and will be updated and published as required / when status changes.Periodic review of Australia and New Zealand documents and procedures.The position will require the incumbent to build effective relationships with local regulators, agencies, and trade organizations to influence direction of regulations, requirements, and performance expectations.Perform local assessments for new partners (e.g., distributors) and help ensure processes are in place at those partners to maintain product and process quality.Perform internal audits for Australia and New Zealand as required.Perform Gap Analysis to help drive consistency between commercial organization and manufacturing facilities. Evaluate and interpret industry regulations and division policies and develop strategies for ensuring Australia and New Zealand are compliant.Responsible as Quality representative for Australia and New Zealand.GENERAL RESPONSIBILITY:This job description describes the principal and main elements of the job. It is a guide to the nature and main duties of the job as they currently exist but is not intended as a wholly comprehensive or permanent schedule and is not part of the contract of employment.MINIMUM BACKGROUND / EXPERIENCE REQUIREDMedical device, Pharmaceutical or related industry experience (10+ years) in a QA Role.Global cross-functional working experiences required.Strong knowledge for ISO 13485, ISO 9001, MDSAP and 21CFR part820Experience in distribution warehouse set-up, qualification, and audit.Experience in process and documentation audit.People management experience is preferred.Knowledge and experience in product development, commercialization, and manufacturing process in IVD medical device preferred.Ability to communicate fluently/effectively in spoken and written English.Ability to develop problem resolution plans that consider both project variables and potential intangible events so that critical to success deadlines are routinely achieved.Must possess a high degree of responsibility and deep sense of ownership for ensuring the highest level for QA standards. Position will require the ability to rapidly retrieve existing standard operating procedures (SOPs), deploy them as required to facilitate commercial business operations and in some cases develop procedural solutions to appropriately resolve quality and compliance challenges.Desired skills/experiences include:Familiarity with regulations such as ISO 9000/13485, QSR.Change management.Experience in working with matrixed organizations.Program/project management.Cross-functional/cross-divisional experiences.Applicable technical knowledge/experience.Audit evaluations and CAPA resolution planning.Ability to develop procedures and policies that clearly define efficient and effective processes needed to ensure compliance and resolve identified problem.Experience in leading and participating in cross-functional teams tasked with QA problem resolution.Experience in training curriculum development.Experienced user of Microsoft Office software: Word, Excel, and PowerPoint.MINIMUM EDUCATION REQUIREDBachelor's degree or equivalentACCOUNTABILITY / SCOPEPrevent problems from occurring to the greatest extent possible by anticipating issues and proactively seeking solutions. Provide guidance and assistance to affiliates to meet business and compliance needs. The guidance, recommendations, feedback, actions and decisions made by the incumbent are critical to assuring compliance with applicable regulatory standards and successfully meeting the business needs and objectives of the division. The impact of such guidance, recommendations and decisions can have a direct effect on the company's ability to distribute existing products. The incumbent is also responsible for assuring distribution partners have adequate systems in place to store, distribute and/or take customer calls. The incumbent must effectively communicate, prepare and negotiate both internally and externally; failure to do so will have a direct impact on market presence.Abbott provides some fantastic benefits for our employees, these include:Leading Learning and Development opportunitiesWellness programsDiscounted share optionsBeing part of an organisation reputed to be a World's Top Employer recognised for our workplace culture that values healthy living, diversity and equal opportunityAbbott 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 isN/A JOB DESCRIPTION: PRIMARY FUNCTION:The incumbent leads the quality efforts of Australia and New Zealand in support of the organization's business objectives. The role is responsible for development, training, implementation, and monitoring of quality systems for ADC Australia and New Zealand organization and working with APAC area as well as division commercial QA organization to ensure full compliance with all laws, regulations, policies, and standards. This is achieved through assuring compliance with existing SOPs, and the development and implementation of additional local SOPs, work instructions, checklists etc., where required. This role is responsible for communication of procedural requirements, training on quality systems requirements and procedures for all affected associates, tracking compliance and the coordination of corrective measures where required.MAIN / MAJOR RESPONSIBILITIESEstablish and aggressively drive the Quality Assurance strategy for Australia and New Zealand by taking ownership and aligning with key Global ADC Quality strategies and direction.Ensure consistent application of relevant Quality Assurance policies, programs, and systems by clearly defining specific Abbott and Abbott Diabetes Care SOPs and locally developed procedures that govern critical to success business functions. Recognition that some degree of flexibility to execute activities appropriate to local requirements and market needs is also required.Elevate issues or significant events (product performance issues) to the appropriate facility with relevant facts and details enough to allow Subject Matter Experts responsible for the product quality and performance to analyze, investigate and provide feedback and corrective actions appropriate to the issue.When quality gaps are identified, and Corrective and Preventive Actions (CAPA) are required, formulate detailed action plans that integrate identified stakeholders, the actions necessary and the required methods and timelines to successfully correct the problem and prevent the issue from recurring / occurring. Ensure CAPAs identified during audits or other means are successfully resolved prior to committed due dates.Work within Australia and New Zealand to lead in audit responses and appropriate corrective actions. Review internal and external audits and respond in to assure any similar deficiencies are also addressed.Sustain ISO9001 certification for Australia.Establish effective partnerships within the business locations to ensure QA needs are identified and successfully met. Respond to manufacturing site requests (e.g., quality holds, reworks, complaint product returns).Organize and develop timely action plans in close coordination with the Regional Customer Service Manager ensuring a seamless execution of successful QA strategies for Australia and New Zealand.Develop and maintain a QA status report covering routine department functions and providing updates on key problem resolution initiatives. Examples may include status of safety alerts, quality holds, field actions (recalls), and CAPAs. The status report will include current projected completion dates and will be updated and published as required / when status changes.Periodic review of Australia and New Zealand documents and procedures.The position will require the incumbent to build effective relationships with local regulators, agencies, and trade organizations to influence direction of regulations, requirements, and performance expectations.Perform local assessments for new partners (e.g., distributors) and help ensure processes are in place at those partners to maintain product and process quality.Perform internal audits for Australia and New Zealand as required.Perform Gap Analysis to help drive consistency between commercial organization and manufacturing facilities. Evaluate and interpret industry regulations and division policies and develop strategies for ensuring Australia and New Zealand are compliant.Responsible as Quality representative for Australia and New Zealand.GENERAL RESPONSIBILITY:This job description describes the principal and main elements of the job. It is a guide to the nature and main duties of the job as they currently exist but is not intended as a wholly comprehensive or permanent schedule and is not part of the contract of employment.MINIMUM BACKGROUND / EXPERIENCE REQUIREDMedical device, Pharmaceutical or related industry experience (10+ years) in a QA Role.Global cross-functional working experiences required.Strong knowledge for ISO 13485, ISO 9001, MDSAP and 21CFR part820Experience in distribution warehouse set-up, qualification, and audit.Experience in process and documentation audit.People management experience is preferred.Knowledge and experience in product development, commercialization, and manufacturing process in IVD medical device preferred.Ability to communicate fluently/effectively in spoken and written English.Ability to develop problem resolution plans that consider both project variables and potential intangible events so that critical to success deadlines are routinely achieved.Must possess a high degree of responsibility and deep sense of ownership for ensuring the highest level for QA standards. Position will require the ability to rapidly retrieve existing standard operating procedures (SOPs), deploy them as required to facilitate commercial business operations and in some cases develop procedural solutions to appropriately resolve quality and compliance challenges.Desired skills/experiences include:Familiarity with regulations such as ISO 9000/13485, QSR.Change management.Experience in working with matrixed organizations.Program/project management.Cross-functional/cross-divisional experiences.Applicable technical knowledge/experience.Audit evaluations and CAPA resolution planning.Ability to develop procedures and policies that clearly define efficient and effective processes needed to ensure compliance and resolve identified problem.Experience in leading and participating in cross-functional teams tasked with QA problem resolution.Experience in training curriculum development.Experienced user of Microsoft Office software: Word, Excel, and PowerPoint.MINIMUM EDUCATION REQUIREDBachelor's degree or equivalentACCOUNTABILITY / SCOPEPrevent problems from occurring to the greatest extent possible by anticipating issues and proactively seeking solutions. Provide guidance and assistance to affiliates to meet business and compliance needs. The guidance, recommendations, feedback, actions and decisions made by the incumbent are critical to assuring compliance with applicable regulatory standards and successfully meeting the business needs and objectives of the division. The impact of such guidance, recommendations and decisions can have a direct effect on the company's ability to distribute existing products. The incumbent is also responsible for assuring distribution partners have adequate systems in place to store, distribute and/or take customer calls. The incumbent must effectively communicate, prepare and negotiate both internally and externally; failure to do so will have a direct impact on market presence.Abbott provides some fantastic benefits for our employees, these include:Leading Learning and Development opportunitiesWellness programsDiscounted share optionsBeing part of an organisation reputed to be a World's Top Employer recognised for our workplace culture that values healthy living, diversity and equal opportunityAbbott 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 isN/A In specific locations, the pay range may vary from the range posted.JOB FAMILY: Operations Quality DIVISION: ADC Diabetes Care LOCATION: Australia > Macquarie Park : 299 Lane Cove Road ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Not specified MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Not ApplicableAbout 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.#J-18808-Ljbffr
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