Medical Devices
7 days ago
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
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