Senior Supplier Quality Technician

JOB DESCRIPTION

This position works out of our Plymouth, MN location in the EP Division.

In Abbott’s Electrophysiology (EP) business, we are 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.

• Assist engineers in developing and maintaining quality engineering methodologies and providing quality technical support within sustaining, manufacturing, or system/services support.
• Perform inspection of production operations, including documenting inspection and audit results. Perform final product inspections against specification and procedural requirements.
• Document nonconformances appropriately 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 evaluating 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.
• Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments. Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

• 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.

• Prior medical device experience.
• Technical degree.
• SAP experience.

$21.55 – $43.05/hour (in specific locations, the pay range may vary from the range posted).

United States >
Minnesota >
Plymouth : 5050 Nathan Lane N

Standard

No

No

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link
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