Quality Technician 1

Abbott Laboratories; Portland (OR); On-site; USD 26,000 - 54,000; Full time

Job summary

Abbott Laboratories in Portland, OR seeks a Quality Engineer to assist in developing and maintaining quality engineering methodologies across new product development, manufacturing, and services support. The role emphasizes process control, data analysis, and documentation of verifications and validations.

You will contribute to compliance with FDA regulations and ISO 13485, and collaborate with engineers to improve test methods and inspection fixturing within the Heart Failure division.

Qualifications

• High School Diploma or GED with 5+ years of related work experience.
• Experience with validations, qualifications, Gage R&R, calibration, test methods, and NCMR dispositioning.
• ASQ CQT certification or equivalent is preferred.

Responsibilities

• Perform production operation inspections and document results.
• Document nonconformances and assist in resolutions.
• Monitor and calibrate test equipment and fixtures.
• Create and maintain control plans for products and processes.
• Write verifications, qualifications, and validations for equipment and products.
• Support FDA, ISO 13485 and applicable regulatory requirements.

Skills

Good communication

Data analysis

Report writing

Computer skills

Education

ASQ CQT certification or equivalent

Tools

Optical measurement

Hand tools

Gages

Fixture design

Blueprint reading

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.

The base pay for this position is $19.35 – $38.75/hour In specific locations, the pay range may vary from the range posted.

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.

JOB FAMILY: Operations Quality

DIVISION: HF Heart Failure

LOCATION: United States

States > Portland : 16125 SW 72nd Ave

ADDITIONAL LOCATIONS:

WORK SHIFT: Standard

TRAVEL: Yes, 10 % of the Time

MEDICAL SURVEILLANCE: No

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)

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.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more.

With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life.

Whether it’s next‑generation diagnostics, life‑changing devices, science‑based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people in all phases.

The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well‑being of millions of people. They push the boundaries to help manage and treat many of life’s greatest health challenges.

We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. Follow Us: Facebook LinkedIn YouTube Twitter