Job Information
Abbott Development Quality Engineer I in Sunnyvale, California
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 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
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
Performs other related duties and responsibilities, on occasion, as assigned
Qualifications/ Experience
Bachelor level degree in Electrical Engineering or Biomedical field required
0-2 years’ 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 travel approximately 10%, including internationally
Ability to maintain regular and predictable attendance
Previous engineering experience preferred
Experience 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.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email corpjat@abbott.com