Incoming Materials Quality Specialist (Medical Devices)

Join our Plymouth, MN team and be a frontline guardian of product quality in a highly regulated environment. In this role, you help operate and improve the site’s quality system aligned with ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, and EU MDR. Your expertise ensures components and in-process products meet exacting standards before they move forward.

At-a-Glance

• Hours: Monday–Friday day shift (start at 6/7/8am) with overtime as needed
• Pay: $20–$23 per hour + quarterly bonus & merit
• Location: 14605 28th Ave North, Plymouth, MN
• Hire Type: Direct, full-time

A Day in the Life

• Conduct precise inspections of incoming components and in-process assemblies using calipers, micrometers, gauges, and other standard metrology tools.
• Flag, segregate, and document nonconforming material; maintain clear, complete records.
• Participate on the Material Review Board, contributing to decisions on nonconformance reports and appropriate dispositions.
• Support nonconformance (NC) disposition activities, including re-inspection and verification.
• Enter and retrieve inspection and NC data within local and global systems (e.g., SAP), producing accurate, high-quality documentation.
• Review associated quality records such as Device History Records (DHRs) and equipment calibration logs.
• Partner with the team on problem-solving and continuous improvement opportunities; perform additional duties as assigned.

Tools & Systems You’ll Use

• Measurement gauges, calipers, and micrometers
• SAP for documentation and data retrieval
• Microsoft Excel and Word for reporting and records

Required Qualifications

• High school diploma/GED and at least 1 year in mechanical inspection or other technical production tasks.
• Comfort with PCs and common desktop apps (Excel, Word).
• Ability to thrive in a fast-paced, deadline-driven setting while producing meticulous documentation.
• Collaborative approach to analyzing and resolving technical issues; capable of managing multiple priorities in parallel.
• Professional, team-first mindset.

Preferred Qualifications

• Experience in Continuous Improvement (CI) or 5S practices.
• More than 1 year as a Quality Inspector within medical device manufacturing/production.
• Hands-on experience with component inspection in a medical device setting.
• Prior experience recording information in SAP or a similar system.
• Working knowledge of calipers, rulers, and metallurgy tools.
• Exceptional attention to detail and adherence to procedures.

Physical Requirements

• Lift/push/pull 25–50 lbs.
• Frequent bending, walking, standing, sitting, and typing.
• Manual dexterity/hand manipulation and strong visual acuity.

Benefits & Growth

We’re committed to supporting your health, well-being, and long-term success.

• Market-competitive, bi-weekly pay
• Benefits effective after 30 days
• Generous PTO plus additional holidays
• Comprehensive medical, dental, and vision coverage
• Short- and long-term disability
• 401(k) with company match
• Maternity and paternal leave
• Optional add-ons/discounts (e.g., Pet Insurance)
• Tuition reimbursement and continuing education support
• Clear paths for advancement and a stable, long-term career

Proficiency Spotlight

• Quality inspection and component inspection
• Weighing raw materials
• Composite materials and repair
• ISO 9001 familiarity
• Medical device environment exposure
• Microsoft Excel and Word
• SAP

Technologies You’ll Touch

• Measurement gauges
• Calipers and micrometers
• SAP