Quality Engineer II

Quality Engineer II

Location: Plymouth, MN
Duration: 7-8 months

Description:
We are seeking a passionate Quality Engineer to assure products, processes, and quality records conform to quality standards and establish compliance within clients’ 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 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 Nonconformance, 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 Client 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 occasionally as assigned.

Manager’s Note:
Investigation for non-conformance
Reporting into operation and manufacturing Looking for
–              Medical Cost Ratios (MCR’s)
–              CAPA investigations
–              Non conformance investigation
–              Good communication
–              2-4 years of experience
–              Medical device background or equivalent background
–              BS degree in engineering or equivalent background / experience