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 103,000 colleagues serve people in more than 160 countries.
We are seeking a passionate Quality Engineer to assure products, processes, and quality records conform to quality standards and establish compliance within Abbott's quality system. We need you to be responsible for maintaining a strong collaborative partnership with multi-functional teams. Help facilitate success by protecting patient safety and meeting business needs. You will be involved in complaint investigation management. This will include challenging activities pertaining to product complaints and providing information on those complaints, including data extraction from the complaint database for our various business partners (e.g. Regulatory, Quality Engineering).
Impact this role will have:
- Follows all regulations and standards for quality, Environmental, Health, Safety, and Energy (EHS&E) Global Policies, Abbott engineering standards, and other governance areas as applicable.
- Implements and maintains the effectiveness of the Quality System.
- Identifies areas of risk with respect to compliance to internal and external requirements.
- Completes Non-conformance, CAPA, and complaint investigations and offers multiple solutions to issues with clear advantages and disadvantages.
- Influences key partners to develop and maintain QA procedures, forms, and systems.
- Leads meetings and communications for QA system information, concerns, and updates.
- Help drive standard methodologies for data trending and tracking and identification of manufacturing related complaints in alignment with Abbott goals.
- Follows U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
- Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Performs other related duties and responsibilities, on occasion, as assigned.
Your experience(s), education and knowledge:
- Bachelor level degree in Engineering, Technical Field, or equivalent (advanced degree preferred)
- 2-5 years technical experience
- Previous Quality assurance/engineering experience and use of Quality tools/methodologies
- Good communication and interpersonal skills
- Advanced computer skills, including statistical/data analysis and report writing skills
- Ability to work within a team and as an individual contributor in a dynamic, changing environment.
- Strong verbal and written communication skills with ability to effectively communicate at multiple levels in the organization.
- Multitasks, prioritizes and meets deadlines in timely manner.
- Excellent organizational and follow-up skills, as well as attention to detail.
Preferred qualifications and education:
- Detailed knowledge of FDA, GMP, and ISO 13485 preferred
- ASQ CQT, CQE, CQA certification preferred
- Six Sigma root cause analysis/problem solving training and experience preferred.