QC Technician

Regulatory Jobs; Portland (OR); On-site; USD 51,148,000 - 102,383,000; Full time

Benefits offered by this job

Health coverage

Retirement savings plan

Tuition reimbursement

Job summary

Abbott, a global healthcare leader, seeks a quality engineering professional to support HF Heart Failure product development in Portland, OR. The role focuses on ensuring quality across new product development, manufacturing, and system/services support.

You will perform inspections, document nonconformances, calibrate equipment, and help maintain process control plans while aligning with FDA, ISO 13485, and internal QMS standards.

Qualifications

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

Responsibilities

• Inspect production operations and document results.
• Document nonconformances and assist in resolution.
• Calibrate and maintain test equipment and fixtures.
• Initiate related documentation changes.
• Perform Process Control and Monitoring of CTQ parameters.
• Create and maintain control plans and verifications.

Skills

Quality inspection

Gage R&R

Calibration

Test methods

NCMR dispositioning

Job description

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.

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 forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical 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.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews.

The base pay for this position is

$17.85 – $35.75/hour

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Operations Quality

DIVISION:

HF Heart Failure

LOCATION:

United States States > Portland : 16125 SW 72nd Ave

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

No

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf