Job Description
Have you ever wanted to make a difference?
At Abbott, you will play a crucial role to help people live more fully at all stages of their lives.
Abbott is a global healthcare leader and our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional products and branded generic medicines.
Our 113,000 colleagues have a daily impact on the life of people in more than 160 countries.Abbott Nutrition
Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active.
Millions of people around the world count on our leading brands – including Similac, PediaSure, Pedialyte, Ensure, Glucerna and ZonePerfect – to help get the nutrients they need to live their healthiest life.
ObjectivesThis Quality Assurance Technician will work within the Quality Assurance organisation on complaint and service activities which support and guide the business in their regulatory obligations in Complaint Handling, Vigilance reporting and Post Market Surveillance activities in Enteral Feeding.
The Quality Assurance Technician will provide support to customers, affiliate organisations, manufacturing operations and AN Device TPMs in response to customer feedback, auditing systems, publishing quality metrics, monitoring the customer complaint data, identify trends and reporting on malfunctions.
All activities are aimed at facilitating ongoing compliance with Abbott quality policies and procedures as well as international regulatory requirements.
The initial 6- 12 months of the role responsibilities will be dedicated to providing Maternity cover to the Enteral Feeding Pump responsibilities associated with the Service Centre and Third-Party Manufacture and then moving into Post Market SurveillanceResponsibilities
- Working with the Quality Assurance Third Party Manager (QA-TPM Manager) and the AN Device Customer Complaints Manager to support the Abbott Nutrition Device business in providing Quality assurance and technical support to AN Device TPMs, Affiliates and other stakeholders in our activities to meet corporate and regulatory timelines.
- Support the complaints team in ensuring all actions assigned to the TPMs are investigated to meet required timelines and are fully compliant with our procedures to fulfil the requirements of the AN Device complaint and CAPA management system.
- Support Abbott Nutrition Device business in executing Complaint Handling, Vigilance Reporting and Post Market Surveillance activities to meet corporate and regulatory timelines.
- Ensure all complaints are investigated to meet required timelines and are fully compliant with our procedures and documented in our complaints management system.
- Proactively investigate and address customer complaints and/or repair data to identify potential issues and prevent/minimise market impact.
- Analysis of Data to identify trends to provide an enhanced customer experience.
- Coordinate the complaint CAPA process for Abbott Nutrition Device products.
- Work collaboratively with teams across the business to resolve customer complaints and serve as point of contact .
- Coordinate the Service Centre Process and KPI's.
- Ensure all documentation is aligned with Abbott Division requirements, MDR/MDD and ISO regulations where applicable.
- A third level certificate or higher qualification; or alternatively a Leaving Certificate or equivalent level of education with a minimum of 2 years' experience working in a regulated manufacturing or quality environment.
- Excellent verbal and written communication skills, able to convey appropriate information with clarity and effectiveness.
- Excellent interpersonal skills with the ability to work independently and in teams with infrequent supervision and reviewing.
- Good analytical, critical thinking and problemsolving skills and the ability to conduct root cause analyses and completion of Quality Data Evaluations where required.
- Experience working knowledge of recognized Quality Management Systems and Global Medical Device regulations (e.g. ISO9001/ ISO13485/ ISO14971/ cGMP / CE
- Ability to drive continuous improvement to ensure a compliant and lean process in all areas of responsibility.
- Good mathematical skills and proficiency with computer software such as Microsoft Word, Excel & Power Point. Competent Power BI user an advantage.
- Auditing experience and advantage.
- Able to travel internationally on request (approximately 5% annually)
EHS Responsibilities:
- Ensure Environmental Health & Safety standards are met and all EHS regulations and procedures are adhered to.
- Demonstrate accountability and responsibility for EHS performance and compliance through active participation and support of Abbott's EHS Program
- Ensure to report any workrelated injuries or illness to employee health and assist in the investigation.
- Active participation and support of Abbott's EHS programs and attend EHS training as assigned.
- Meet EHS plant goals.