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Medical Devices

2 months ago

Salt Lake City, United States Compunnel Full time

We are seeking a detail-oriented Medical devices Quality Inspector to join our team. This role is crucial in ensuring our products meet the highest standards of quality and compliance.

Title: Quality Inspector I

Location: Salt Lake City, UT, USA, 84123

Shift (12 hr.) rotating shift - 6:30PM - 6:30AM

Duration: 12 Months Possibility of extension

The Quality Inspector will perform entry-level inspection tasks, including visual inspections and basic functional testing. The role involves ensuring company products comply with internal and external specifications through various routine and non-routine inspections and evaluations. The ideal candidate will be proficient in using inspection tools such as microscopes, calipers, and micrometers, and able to complete 10-15 different types of inspections.

Essential Duties & Responsibilities

  • Perform accurate mechanical, physical, and visual inspections of raw materials, components, and sub-assemblies according to inspection plans and specification requirements
  • Conduct PCI activities for NA Notifications at the US Regional Service Center as needed
  • Follow all procedural requirements to maintain compliance with applicable Quality System Regulations (e.g., cGMP compliance)
  • Support paper document archival process, including preparation of pallets for shipment and scanning documents for electronic archival in Agile
  • Initiate Non-Conformance reports as required
  • Support NC and CAPA activities as needed
  • Work on special projects as they arise

Knowledge, Skills & Qualifications

  • Minimum High School graduate or GED equivalent; AA or Technical Degree preferred
  • Basic computer skills for regularly accessing and documenting information
  • Basic written and oral communication skills to interact with team members, understand verbal instructions, and comprehend written work instructions, including words and engineering drawings
  • Demonstrated knowledge of medical device regulations and FDA regulatory standards preferred

Education and Experience

  • High School Diploma required

Minimum Qualifications

  • Must be at least 18 years of age

Travel Requirements

  • Typically requires travel less than 5% of the time

Physical Requirements and Work Environment

  • Ability to perform essential job functions in an office environment
  • Long periods of sitting to enter/analyze data is expected
  • Adequate manual dexterity to operate standard office equipment
  • Ability to occasionally lift objects up to 25 lbs

If you're passionate about quality control and have a keen eye for detail, we encourage you to apply for this position. Join our team and play a crucial role in maintaining the high standards of our products