Engineer II Quality Systems
AbbottAbout the role
JOB DESCRIPTION:
Engineer II Quality Systems
About Abbott
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:
Career development with an international company where you can grow the career you dream of.
Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
An excellent retirement savings plan with high employer contribution
Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
We are currently seeking a highly capable Engineer II Quality Systems to support Abbott’s Structural Heart (SH) Division at our Westfield, IN location. Our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease.
This position is responsible for developing and maintaining quality systems and providing quality system support for the division (e.g. commercialized products, new product development, manufacturing, and/or system compliance).
What You’ll Work On
Provides Quality System Body of Knowledge support to Division and organization.
Implements and conducts data analysis, systems evaluation, and product assessment to ensure finished products meet standards and specifications; implement and drive changes where needed.
Investigates, and resolves system nonconformance’s (defined during internal and/or external audits.
Works with product development and production engineers during product development process to ensure quality deliverables (FMEA, Control Plans, Risk Management) are in place prior to Design Transfer phase gate.
Ensures compliance to ISO 13485 & 21CFR 820 Quality System Regulations by providing support for interpretation of regulations, performing gap analysis and lead activities to implement improvements.
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
As appropriate, utilizes Six Sigma and other quality tools to implement process improvements to enhance product quality and reduce process variance by identifying improvement opportunities in divisional quality system compliance, device, and process.
Analyzes quality audit findings and recommends modifications in products or standards. Proactively identifies opportunities for system compliance improvement and leads activities to implement improvements.
As appropriate, participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality System function as a Team Member)
As appropriate, participate in or lead in the completion and maintenance of risk analysis, as related to quality systems.
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 duties as assigned.
Required Qualifications
Education
Bachelors Degree (± 16 years) In Engineering or Techn
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