Abbott Hiring for Senior Quality Engineer at Pleasanton, California Full Time

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 113,000 colleagues serve people in more than 160 countries.

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 103,000 colleagues serve people in more than 160 countries.

JOB SUMMARY:

This position is responsible for supporting sustaining activities for the Operations Quality Engineering group.

JOB DUTIES:

• Lead all activities for Non-Conformance Material Report’s (NCMR’).

• Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)

• Support CAPA Teams that are addressing manufacturing or design related issues.

• Lead Test Method Validation (TMV) and Inspection Method Validation (IMV) activities.

• Review and approve Process Failure Mode and Effects Analysis (pFMEA)Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ), Product Performance Qualification (PPQ).

• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

• Develop Product Risk Assessment’s for patient safety for CAPA’s and other projects.

• 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

• Performs other related duties and responsibilities, on occasion, as assigned.

• Lead projects within the Operations Quality Engineering group

QUALIFICATIONS:

• BS degree in Engineering or Technical Field or equivalent experience; advanced degree preferred. Electrical Engineering Degree and/or Test Fixture background is a Plus.

• Minimum 7 years experience

• Quality Engineering experience supporting sustaining production activities.

• Solid communication and interpersonal skills

• Project management and leadership skills

• Computer skills, including statistical/data analysis and report writing skills

• Prior medical device experience preferred

• 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.

• LOCATION

Pleasanton, California, United States of America

CAHF Cardiac Arrhythmias & Heart Failure

Yes, 5 % of the Time

Not Applicable

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 [email protected]