Senior Quality Engineer - Electrical

Abbott   •  

Sunnyvale, CA

Industry: Healthcare

  •  

5 - 7 years

Posted 176 days ago

This job is no longer available.

JOB DESCRIPTION:

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.    

Responsibilities:

  • 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  
     

Qualifications:

  • 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