Incoming Quality Technician I

Abbott (abbottcareers2 board); United States; Sur place; USD 25 000 - 39 000; Plein temps

Résumé du poste

Abbott’s Irving, TX site seeks an Incoming Quality Technician I to perform inbound material inspections and tests, ensuring products meet requirements and GMP standards. The role supports manufacturing with hand tools, calipers, gauges, and documentation to maintain quality records.

Under supervision, you will uphold FDA and ISO requirements, document non-conformances, and contribute to process improvements within a fast-paced healthcare environment.

Qualifications

• Inbound material inspection and testing to verify product conformance.
• Maintain accurate inspection records and documentation.
• Comply with GMP, FDA regulations and quality system requirements.
• Identify and report non-conformances and contribute to CAPA.
• Operate inspection equipment and hand tools as required.

Responsabilités

• Supports manufacturing and testing operations adhering to Good Manufacturing Practices to satisfy regulatory requirement.
• Ensures parts are compliant for all parts going to the manufacturing floor and to customers.
• Performs tier 1 inspections per the plan using calipers, gauges and rulers.
• Performs visual and dimensional inspections of cable harness and PCB assemblies.
• Maintains inspection records and documentation per quality and GMP.
• Accepts or rejects supplier lots based on inspection results.
• Documents non-conformance via proper paperwork and system transactions.
• Initiates discrepant material reports and trend data.
• Supports QMS, EMS and regulatory requirements.

Connaissances

Inspection

Quality systems

GMP compliance

Documentation

Outils

Calipers

Gauges

Rulers

Description du poste

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 family, be your true self and live a full life. You'll also have access to:

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 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

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.

Our location in Irving, TX, currently has an opportunity for Incoming Quality Technician I. Under general supervision, the IQA Technician I 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). Failure to adequately perform tasks can result in noncompliance with governmental regulations typically isolated to individual supplier lots.

What You’ll Work On

• 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 inspections per the inspection plan and associated drawings in support of build schedules. Tier 1 inspections includes 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.
• Performs visual and dimensional inspections through application of cable harness assembly and printed circuit board assembly.
• Maintains accurate inspection records, filing systems and appropriate documentation to conform to all quality and GMP regulations.
• Accepts and rejects supplier lots based on inspection results.
• 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).
• Initiates discrepant material reports.
• Assists in gathering, analyzing and trending of data.
• Recommends changes to policies and procedures.
• Takes initiative to ensure work is done accurately and completely. Performs assignments of moderate complexity. Applies existing work methods to different known situations. Problems involve recurring, routine situations; usually refers more complex problems to supervisor or more senior level personnel within the Quality organization.
• 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 procedure.