Sunnyvale, California, USA
3 days ago
Development Quality Engineer I

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 114,000 colleagues serve people in more than 160 countries.

Job Summary

We are seeking an experienced, high caliber Engineer I, Development Quality. This position assures new or modified products conform to quality standards and establishes compliance with the quality system.  Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.  Each employee can make a difference at Abbott and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.    

What you will be doing

Perform Failure investigations of CRM product returnsDocument and generate failure analysis reports in the Complaint Handling System.Support CAPAs in the Corrective Action SystemProvide feedback and background information of returned product investigations to the Customer Quality Support Group and to Postmarket SurveillanceSupport internal & external audit responsesComplete Document Change Request Reviews in a timely and objective manner  Additional duties may be identified by functional management based on the current project/business objectivesSupport all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirementsComplies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignmentsMaintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendorsPerforms other related duties and responsibilities, on occasion, as assigned  
 

Qualifications/ Experience

Bachelor level degree in Electrical Engineering or Biomedical field required0-2 years’ experience - Solid communication and interpersonal skillsAbility to work in a highly matrixed and geographically diverse business environmentAbility to work within a team and as an individual contributor in a fast-paced, changing environmentAbility to leverage and/or engage others to accomplish projectsStrong verbal and written communications with ability to effectively communicate at multiple levels in the organizationMultitasks, prioritizes and meets deadlines in timely mannerStrong organizational and follow-up skills, as well as attention to detailAbility to travel approximately 10%, including internationallyAbility to maintain regular and predictable attendance  Previous engineering experience preferredExperience working in a broader enterprise/cross-division business unit model preferred



The base pay for this position is $72,100.00 – $114,700.00. In specific locations, the pay range may vary from the range posted.

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