Quality Engineer, Product Performance

at Abbott Laboratories
Location Not Specified, California
Date Posted July 31, 2022
Category Engineering
Job Type Not Specified

Description

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.

Quality Engineer, Product Performance Sustaining (Post Market)

Santa Clara, CA

Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of STRUCTURAL HEART disease. We aim to lead the markets we serve by requiring the solutions we offer customers provide an improved benefit/risk profile as compared to existing standards of care; a performance threshold that guides and ensures the productive output of our engineering, business development, and clinical research efforts result in outcomes that advance the standard of care.

WHAT YOU LL DO

The Quality Engineer, Product Performance will initiate medical device quality assurance activities in our Structural Heart division. In this role, you will identify, analyze, investigate, monitor, and document patterns and trends in post market surveillance data as part of the CAPA system. You will analyze and investigate product complains from the field as part of post market surveillance requirements.

This position will support the assessment of regulations and product standards as well as the implementation activities that are required to claim compliance. Activities will include assessing applicability, performing a gap assessment, developing an implementation plan, and executing to the implementation plan. You will interact with cross function members where needed to complete the assessments. You will also update and maintain the quality system for external requirements systems management to continue to drive to be best in class.

Duties and Responsibilities:

  • ResponsibleforcompliancewithapplicableCorporateandDivisionalPoliciesandprocedure

  • Analyzecustomercomplaints,eventsandotherpostmarketingsurveillancedatabyexaminingreturned devices and datafor patternsandtrendsandinvestigatingwhennecessary.;

  • Investigatecustomercomplaintsrelatedtoproduct qualityorpatientsafety

  • Provideinputforprocessimprovementandhelpdevelopstacticalapproachestoimplement teamstrategies.;

  • Planandorganizenon-routinetasksw/approval.Initiatesor maintainsworkschedule.Establishesprioritiesofworkassignments

  • Exercise judgmentinselectinginnovative,practicalmethodstoachieve problemresolution.

  • Assess the applicability of regulations and standards to the Structural Heart Business unit.

  • Perform a gap assessment of applicable regulations and standards and use templates to complete write up of tasks and place into Windchill.

  • Follow SOPs and Wis to complete duties as assigned.

  • Collaborate with other teams working on special 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.

EDUCATION AND EXPERIENCE YOU LL BRING

Required

  • Bachelor level degree in Engineering, Technical Field, or equivalent

  • 2+ years technical experience in Engineering or Quality

  • Experience in the medical device industry

  • Experience with returns (device returns)

  • Experience with Failure Analysis

  • Ability to travel approximately 10%

Preferred

  • Previous Quality assurance/engineering experience and demonstrated use of Quality tools/methodologies

  • Detailed knowledge of FDA, GMP, and ISO 13485

  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

  • Multitasks, prioritizes, and meets deadlines in timely manner.

  • Experience performing gap assessments preferred

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

  • Training and career development, with onboarding programs for new employees and tuition assistance

  • Student Loan Repayment Program

  • Financial security through competitive compensation, incentives and retirement plans

  • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs

  • Paid time off

  • 401(k) retirement savings with a generous company match

  • The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully:

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at , on Facebook at and on

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