Incoming Materials Quality Specialist; Medical Devices

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, MNHire Type:
Direct, full-timeA 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 repairISO 9001 familiarity

Medical device environment exposure

Microsoft Excel and WordSAPTechnologies You’ll Touch Measurement gauges

Calipers and micrometers SAP