Demo

Quality Inspector, Manufacturing Floor

Switchback Medical
Minneapolis, MN Full Time
POSTED ON 4/7/2025
AVAILABLE BEFORE 5/5/2025

Job Description

Job Description

Summary :

Perform Quality Management System activities including in-process, final quality inspection, and first article inspections. Monitor manufacturing activities including proper completion of paperwork and use of test methods. Perform duties to support established procedures and quality guidelines. Work with cross-functional sustaining teams to ensure safety, quality and compliance of products. This position will primarily be working on the manufacturing floor.

Essential Duties and Responsibilities :

  • Lead quality in-process and final testing efforts to satisfy pre and post market product requirements.
  • Perform dimensional inspections using laser micrometers, vision systems, mandrels, go / no- go fixtures, rulers, indicators, calipers and micrometers.
  • Manage and review assembly records to ensure proper kitting materials, training status of assemblers, equipment and calibration, documentation practices, etc.
  • Initiate Non-Conforming Material Requests as necessary, work with team to determine appropriate actions and dispositions.
  • Execute tasks that assist in identifying, communicating, and resolving quality issues.
  • Maintain component identity by following established documentation and traceability processes.
  • Follow established safety procedures and perform duties in a safe manner.
  • Identify and diagnose problems and follow through to resolution.
  • Asist with First Article Inspections.
  • Perform other tasks as assigned or as required to function as a member of a work team.
  • Perform all duties of this position in accordance with FDA and ISO 13485 standards.
  • Ability to work with a variety of personnel.

Technical Skills :

  • Expert in quality inspections including use of measurement tools as required.
  • High level of attention to detail.
  • Highly proficient with MS Office (Word, Excel, Access), Adobe Acrobat, internet and e-mail systems. Solid understanding of software capabilities and business applications associated with Grand Avenue Software.
  • Understanding of Quality System Documentation, including good documentation practices.
  • Excellent organization and filing skills.
  • Ability to learn and apply good manufacturing practices and inspection processes as well as ISO 13485 and FDA requirements.
  • Must be able to determine and use sampling plans.
  • Use and be familiar with measuring tools functionality and accuracy requirements.
  • Ability to read and comprehend component / material drawings / prints.
  • Knowledge of basic manufacturing concepts and workflow preferred.

  • Ability to perform basic math operations including addition, subtraction, multiplication and division, as well as knowledge of basic geometry.
  • Education / Experience :

  • High School diploma or equivalent, with 6 years’ relevant experience.
  • 2 year college degree preferred (may reduce experience required).
  • Minimum of two years’ experience with quality system documentation and electronic systems.
  • Experience in medical device inspection required.
  • This job description is intended to describe the general nature and level of work being performed by employees assigned to this position. It is not intended to be an entire list of all activities, tasks and skills required of employees in this position.

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