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Abbott IQA Technician II, 2nd Shift in Irving, Texas

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 109,000 colleagues serve people in more than 160 countries.

Please note: This is a 2nd shift position. Work schedule: 2:00 p.m. - 11:30 p.m. Monday through Friday. Potential weekend shift

ABOUT ABBOTT DIAGNOSTICS:

The key to successful treatment and full recovery is often fast, accurate diagnosis. Abbott’s life-changing tests and diagnostic tools provide insights that enable smarter, faster decisions and transform the way the world is managing health.

Our pioneering technology spans the world of healthcare operations — with medical diagnostic instruments, tests, automation and informatics solutions for hospitals, reference labs, blood centers, emergency departments, physician offices and clinics.

Under limited supervision, the IQA Technician II performs inbound material inspections and tests that evaluate the precision and accuracy of products and services. The inspector’s approval certifies the services or material conform to existing requirements, standard operating procedures, Abbott’s quality system requirements, government regulations and adheres to all Good Manufacturing Practices (GMP). Assignments require broad judgment in troubleshooting proven processes as well as the ability to suggest alternatives. Will provide technical assistance to support manufacturing efforts by implementing corrective and preventative actions. Failure to adequately perform tasks can result in noncompliance with governmental regulations typically isolated to individual supplier lots and all future lots for automated testing.

Our location in Dallas, TX currently has an opportunity for a Incoming Quality Technician II, 2nd Shift

WHAT YOU’LL DO

  • Supports manufacturing and testing operations adhering to Good Manufacturing Practices and Good Laboratory Practices to satisfy regulatory requirement for receiving and inspection.

  • Performs all job duties in full accordance with the Abbott Global and Technical standards and complies with Abbott Quality System (QS) requirements. Ensures parts are compliant for all parts going to the manufacturing floor and any parts going directly to the customer.

  • Completes tier 1 & tier 2 inspections to test inbound material that will be used to assemble complex medical devices:

  • Tier 1 inspections:

Manual routine inspections utilizing hand tools such as calipers, gauges (ring, pin, thread, height), rulers as well as visual inspections to test inbound material that will be used to assemble complex medical devices. May operate upper level instrumentation.

  • Tier 2 inspections:

Operate and program advanced upper level instrumentation: 3D/2D Digital Measuring projector and/or Optical Testing and Visualization Instruments (e.g. Optical Gaging Product (OGP), Keyence IM, etc.)

Performs inspection on printed material (e.g. Primary and Secondary labeling; manuals; print inserts; CD’s; etc.).

Performs first article inspections

  • Accepts and rejects supplier lots based on inspection results. The information gathered is used by others to make both critical and strategic decisions.

  • Documents the non-conformance or suspected non-conformance to standards (i.e. manufacturing documentation, material/ component specifications, operating procedures, and domestic/ international standards) through the identification of unsuccessful audits, the completion of required paperwork, system transactions, and affixing his or her mark (i.e. stamp, sign-off or signature).

  • Reviews applicable sampling plans and control plans to verify product and services conform to quality and other engineering and Quality Assurance requirements.

  • Interprets drawings and develops the automated testing to ensure the specifications of the drawing are met.

  • Initiates discrepant material reports

  • Develops standardized part specific inspection methodologies.

  • Performs comparison between supplier and internal measurement/inspection methods.

  • Provides alternative inspection methods.

  • Uses technical knowledge to acquire, analyze, and interpret data. Applies information and methods for problem solving.

  • Assignments require considerable judgment, initiative, creativity and leadership in troubleshooting, suggesting alternatives, and making recommendations for continuous quality improvement.

  • Performs set-up, testing, and troubleshoots all area-specific equipment, materials, systems, and/or product.

  • Supports 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, ISO or other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

  • Adheres to all environmental, health and safety SOP’s, equipment, policies and procedures, including any department specific requirements.

You’ll be accountable for meeting our compliance standards including FDA, OSHA and Abbott policies and procedures.

EDUCATION AND EXPERIENCE, YOU’LL BRING

Required

  • High School Diploma or GED required

  • 2-5 years’ experience

  • Previous experience in Quality performing inspection. Previous experience working with Vision system.

  • Experience with optical measurement equipment, hand tools, gages, pressure and force gage testing

  • Training in blueprint reading and experience with inspection sampling techniques

  • Knowledge of FDA, GMP, ISO 13485.

  • Good communication and computer skills, including Microsoft Word and Excel.

Preferred

  • Bachelor’s degree

  • Zeiss CMM programmer

  • Keyence program/operation experience preferred

  • Basic knowledge of Geometric Dimensioning and Tolerancing (ASME Y14.5-1994)

  • 2 years of experience in a highly regulated industry

  • Proficient with Microsoft office suite

  • Demonstrated ability to proficiently read blueprints and apply to job duties.

  • Strong problem-solving skills

  • Prior medical device component inspection experience preferred

  • ASQ CMI certification

  • Demonstrated ability to proficiently apply knowledge in machining and/or Quality Systems inspection to accomplish departmental goals and objectives.

  • Able to interpret Engineer part drawings

  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.

  • Ability to leverage and/or engage others to accomplish projects.

  • Strong organizational and follow-up skills, as well as attention to detail.

  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

  • Training and career development , with onboarding programs for new employees and tuition assistance

  • Financial security through competitive compensation, incentives and retirement plans

  • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs

  • Paid time off

  • 401(k) retirement savings with a generous company match

  • The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx)

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. 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 and @AbbottGlobal.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com

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