QC Technician

Abbott; Portland (OR); On-site; USD 51,148,000 - 102,438,000; Full time

Job summary

Abbott is a global healthcare leader dedicated to helping people live fuller lives. This role sits in the Heart Failure Division at our Portland, OR location, supporting quality engineering in new product development, manufacturing, or services.

You will assist engineers in developing and maintaining quality methodologies and provide technical quality support. The position emphasizes inspections, data analysis, and documentation, with a focus on regulatory compliance and improving processes in a

Qualifications

• High School Diploma or GED required.
• 5+ years related work experience in quality engineering.
• Experience with validations, qualifications, Gage R&R, calibration.

Responsibilities

• Perform inspections of production operations and document results.
• Document nonconformances and assist in resolutions.
• Monitor calibration of test equipment and fixtures.
• Create and maintain control plans for products and processes.
• Support QMS/EMS compliance and FDA regulatory requirements.

Skills

Quality engineering

Documentation

Statistical analysis

Communication

Education

High School Diploma / GED

Tools

Gage R&R

Calibration

Test methods

Blueprint reading

Measurement equipment

Job 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 122,000 colleagues serve people in more than 160 countries.

Job Description

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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.
• 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.
• A company recognized as a great place to work in dozens of countries worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Portland, OR location in the Heart Failure Division. In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, 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 new product development, manufacturing, or system/services support.

What You’ll Work On

• 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.

Required Qualifications

• High School Diploma/ GED
• 5+ years Related work experience. Previous experience in assisting with validations & qualifications, Gage R&R, calibration, test methods, and NCMR dispositioning

Preferred Qualifications

• Knowledge of Quality Systems, FDA regulations, ISO 13485 and applicable worldwide regulatory requirements.
• Experience with optical measurement equipment, hand tools, gages, pressure and force gage testing, and fixture design.
• Training in blueprint reading and experience with sampling techniques.
• Good communication and computer skills, including data analysis and report writing skills.
• Prior medical device experience preferred.
• ASQ CQT certification or equivalent preferred.

Abbott is an Equal Opportunity Employer, committed to employee diversity.

The base pay for this position is $17.85 – $35.75 per hour. In specific locations, the pay range may vary from the range posted.