Senior Supplier Quality Technician

Abbott • Plymouth, MN

13d • $22 - $43 • Onsite

About The Position

This position works out of our Plymouth, MN location in the EP Division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. This position is responsible for assisting engineers in developing and maintaining quality engineering methodologies and providing quality technical support within sustaining, manufacturing, or system/services support.

Requirements

• High school diploma/GED or an equivalent combination of education and work experience
• Minimum of 5 years of related work experience including: Previous experience in assisting with First Article Inspections (FAIs), Gage R&R studies, validations, calibration, test methods, and NCMR dispositioning.
• Knowledge of Quality Systems, FDA regulations, ISO 13485, GMP, and applicable worldwide regulatory requirements.
• Experience with optical measurement equipment, hand tools, gages, pressure and force gage testing
• Experience with sampling techniques
• Good communication and computer skills, including data analysis and report writing skills.

Nice To Haves

• Prior medical device experience
• Technical degree
• SAP experience

Responsibilities

• Perform inspection of production operations, including documenting inspection and audit results. Perform final product inspections against specification and procedural requirements.
• Document nonconformances as appropriate and assist in the resolution of nonconformances.
• Monitor and/or perform calibration and maintenance of all test equipment and fixtures.
• Initiate related documentation changes.
• Perform Process Control & Monitoring of critical-to-quality parameters and specifications.
• Collect data, summarize, analyze, perform basic statistical analysis on, and document test results.
• Assist with or perform Gage R&R studies.
• Assist with the selection, installation and programming of precision measuring equipment.
• Assist in designing, building, and evaluation of test methods and inspection fixturing, providing improvement recommendations.
• Create and maintain control plans for products and processes.
• Assist in writing, executing and documenting equipment, product, process, and test method verifications, qualifications, and validations.
• 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.

Benefits

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: High school or GED