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Senior Quality Assurance Engineer

2 months ago

Liberty, South Carolina, United States Abbott Laboratories Full time

About Abbott Laboratories

Abbott Laboratories 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.

Our Mission

We're always looking towards the future, anticipating changes in medical science and technology. Our mission is to create breakthrough science to improve people's health.

What We Offer

  • A career with a company that can help you build your future and live your best life.

  • Access to career development opportunities with an international company.

  • 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.

  • 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.

The Opportunity

This position works in the Cardiac Rhythm Management division. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.

Job Summary

We are seeking a high caliber Senior Quality Assurance Engineer who will work under general supervision, builds routines for non-contact inspection equipment to support incoming inspection activities. Interprets drawing & blueprint requirements and applies test or inspection methods to verify requirements. Performs tests according to written protocols; adjusts incoming inspection plans to support supplier quality engineering; maintains accurate written and electronic records; develops special tests; troubleshoots and repairs equipment. Takes initiative to ensure work is done accurately and completely. Applies existing work methods to different known situations. Solves problems involve recurring, routine situations; usually refers more complex problems to supervisor or more senior level personnel.

Key Responsibilities

  • Builds & validates routines for non-contact inspection equipment; troubleshoots issues with automated routines.

  • Interprets blueprints and drawing GD&T; applies known test methods or suggests new test methods to verify requirements.

  • Builds special test routines; supports Gage R&R and Measurement System Analysis studies; automate portions of laboratory and manufacturing processes.

  • Adjusts inspection plans in SAP to support First Article Inspections, process average adjustment, quality issue resolution and other quality process.

  • Keeps laboratory and equipment neat, functional, calibrated and well maintained.

  • Maintains a database of information on ongoing testing; prepares data spreadsheets; ensures integrity of data.

  • Utilizes the document control & change management systems and processes to ensure accuracy of documentation and to continuously improve processes & procedures.

  • Recommends changes to measurement procedures to enhance turn-around time or give better readings.

  • May set-up utilize special test equipment.

  • May participate in preventative maintenance activities for non-contact measurement equipment and other general measurement equipment.

  • Notifies supervisor of the need to replenish supplies/materials and of any production difficulties that cannot be readily corrected.

  • 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.

Requirements

  • High School Diploma / GED And trade school certification, specialized training/apprenticeship and/or equivalent background in Electronics, Electrical Technology, a related discipline, or specialized training which provides a theoretical understanding of electronic disciplines.

  • Associates Degree In a relevant discipline, equivalent trade school/military training, or comparable related experience in the biomedical field is desired.

Preferred Experience

  • Demonstrated proficiency with non-contact measurement equipment such as OGP Smart Scope, Mitutoyo Quick Vision & Keyence IM systems