Quality Inspector (Components)

The Quality Inspector is responsible for assisting in administration of the quality functions at a site to assure adherence to ISO 9001 ISO 13485 MDSAP FDA 21 CFR Part 820/211 EU MDR and other applicable regulatory standards. Quality Inspectors support manufacturing and servicing operations by performing incoming component and in-process product inspections using standard measurement equipment. They identify segregate and document rejected material and participate in Material Review Boards to ensure the proper documentation and disposition. They may also review other related Quality documentation such as device history or calibration records.

HOURS: Monday - Friday dayshift 6/7/8am start time overtime as needed
PAY: $20-23hr quarterly bonus & merit
LOCATION:th Ave North Plymouth MN
HIRE: Direct full time.

• Conducts incoming component and in-process product inspections to approprite standards.
• Identifies segregates and documents rejected components and materials.
• Participates on a Material Review Board to review and process non conformance reports.
• Supports NC disposition activities such as re-inspection.
• Enters and retrieves inspection and Nc data from local and global systems.
• Reviews related Quality documentation such as DHRs or calibration records.
• Supports local problem solving activities and may identify opportunities for improvement.
• Complete other duties as assigned.

Required:

• HS Diploma/GED 1yr of experience in mechanical inspection or other technical production tasks.
• PC experience and working familiarity of common desktop applications including Excel and Word.
• Ability to work in a fast-paced environment with strict deadlines generate detailed high-quality documentation work with others in analyzing and solving technical problems and perform/manage multiple tasks in parallel.
• Ability to work in a professional manner to support team actions and effectively manages work tasks.

Preferred:

• Experience working in a Continuous Improvement (C.I.) or 5S environment.
• Over 1yr of Quality Inspector experience at a Medical Device manufacturing/production company.
• Experience with component inspection specifically in medical device production.
• Previous experience documenting information in SAP or similar system.
• Knowledge and working experience using calipers rulers and other metallurgy tools.
• Keen eye for detail and process/procedure adherence.

Other:

• Lifting pushing pulling 25-50lbs.
• Bending walking standing sitting typing hand manipulation visual acuity.

We value our employees and are committed to providing a comprehensive benefits package that supports your health well-being and financial future.

Here is just a brief overview of what we offer:

• Market Competitive Pay (bi-weekly).
• Benefits after 30 days.
• Extensive Paid Time Off and added holidays.
• Excellent Healthcare Dental and Vision Benefits.
• Long/Short Term disability coverage.
• 401(k) with company match.
• Maternity & Paternal Leave.
• Additional add-on benefits/discounts for programs such as Pet Insurance.
• Tuition Reimbursement and continued educations programs.
• Excellent opportunities for advancement and stable long-term career.