Senior Quality Engineer - Electrical

Abbott   •  

Sunnyvale, CA

Industry: Healthcare


5 - 7 years

Posted 245 days ago

This job is no longer available.


We are seeking an experienced, high caliber Senior Quality Engineer. 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.    


  • Perform Failure investigations of Cardiac Rhythm Management (CRM) product returns
  • Document and generate failure analysis reports in the Complaint Handling System.
  • Support CAPAs in the Corrective Action System
  • Provide feedback and background information of returned product investigations to the Customer Quality Support Group and to Postmarket Surveillance
  • Support internal & external audit responses
  • Complete Document Change Request Reviews in a timely and objective manner  Additional duties may be identified by functional management based on the current project/business objectives
  • Generate work instructions for lab processes
  • Support qualification/validation of lab fixtures and equipment
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
  • Complies with 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
  • May have supervisory roles assigned
  • Performs other related duties and responsibilities, on occasion, as assigned  


  • Bachelor level degree in Electrical Engineering or Biomedical field required
  • 5+ years of experience
  • Solid communication and interpersonal skills
  • Ability to work in a highly matrixed and geographically diverse business environment
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment
  • Ability to leverage and/or engage others to accomplish projects
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
  • Multitasks, prioritizes and meets deadlines in timely manner
  • Strong organizational and follow-up skills, as well as attention to detail
  • Ability to maintain regular and predictable attendance  
  • Previous engineering experience preferred
  • Experience working in a broader enterprise/cross-division business unit model preferred