Quality Inspector (Components)

Quality Inspector supporting manufacturing and servicing operations through inspections, documentation, and compliance with regulatory standards including ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, and EU MDR.

Responsibilities

• Conducts incoming component and in-process product inspections to appropriate standards.
• Identifies, segregates, and documents rejected components and materials.
• Participates on a Material Review Board to review and process non-conformance reports.
• Supports non-conformance disposition activities such as re-inspection.
• Enters and retrieves inspection and non-conformance data from local and global systems.
• Reviews related Quality documentation such as Device History Records (DHRs) or calibration records.
• Supports local problem-solving activities and identifies opportunities for improvement.
• Completes other duties as assigned.

Requirements

• High School Diploma or GED plus 1 year of experience in mechanical inspection or other technical production tasks.
• PC experience and working familiarity with common desktop applications including Excel and Word.
• Ability to work in a fast-paced environment with strict deadlines, generate detailed, high-quality documentation, and work with others to analyze and solve technical problems.
• Ability to perform and manage multiple tasks in parallel while maintaining professionalism and supporting team actions.
• Lifting, pushing, pulling 25-50 lbs; bending, walking, standing, sitting, typing, hand manipulation, and visual acuity.

Preferred Qualifications

• Experience working in a Continuous Improvement (C.I.) or 5S environment.
• Over 1 year 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 adherence to processes/procedures.

Benefits

• Market-competitive pay (bi-weekly) with quarterly bonus and merit opportunities.
• Benefits eligibility after 30 days, including extensive paid time off and added holidays.
• Comprehensive healthcare, dental, and vision benefits.
• Long/short-term disability coverage.
• 401(k) with company match.
• Maternity and paternal leave.
• Additional add-on benefits/discounts (e.g., pet insurance).
• Tuition reimbursement and continued education programs.
• Opportunities for advancement and stable long-term career growth.

Pay

$20–$23 per hour. This position is eligible for bonus participation.

Schedule

Monday–Friday dayshift with a 6/7/8 AM start time, plus overtime as needed.

Location: 14605 28th Ave North, Plymouth, MN. Direct, full-time hire.