Quality Inspector II

Abbott LaboratoriesMinnetonka, MN
112d$19 - $38

About The Position

As a Quality Inspector II at Abbott, you will work in the Vascular Division located in Minnetonka, MN. This position is essential for assisting engineers in developing and maintaining quality engineering methodologies and providing quality technical support within new product development, manufacturing, or system/services support. You will perform inspections of purchased components and production operations, document inspection results, and ensure compliance with FDA regulations and other quality standards.

Requirements

  • Associates degree, completion of a 2-yr technical program or equivalent experience and demonstrated competence.
  • 2-4 years' experience.
  • Previous experience in assisting with validations & qualifications, Gage R&R, calibration, test methods, and NCMR dispositioning.
  • 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.
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
  • Multitasks, prioritizes and meets deadlines in timely manner.
  • Strong organizational and follow-up skills, as well as attention to detail.

Nice To Haves

  • Prior medical device experience.
  • ASQ CQT certification or equivalent.
  • Experience working in a broader enterprise/cross-division business unit model.

Responsibilities

  • Perform first article incoming inspection of purchased components and inspection of production operations, including documenting inspection and audit results.
  • Perform final product inspections against specification and procedural requirements.
  • Document nonconformances as appropriate.
  • 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, and document test results.
  • Assist with or perform Gage R&R studies.
  • Assist with the selection, installation and programming of precision measuring equipment.
  • 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.
  • Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Benefits

  • Free medical coverage in the Health Investment Plan (HIP) PPO medical plan in the next calendar year.
  • Excellent retirement savings plan with high employer contribution.
  • Tuition reimbursement and the Freedom 2 Save student debt program.
  • FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.

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What This Job Offers

Job Type

Full-time

Career Level

Entry Level

Industry

Computer and Electronic Product Manufacturing

Education Level

Associate degree

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