Manufacturing QE

Posted: 02/12/2025 Location: Maple Grove, Minnesota, United States Salary: $85000 - $110000 Job type: Permanent

Title: Manufacturing Quality Engineer

Location: Onsite

Employment Type: Full-Time

Overview

This role supports day-to-day quality activities on the manufacturing floor and provides hands-on support for validation, documentation updates, investigations, and process improvements. It's a strong opportunity for an engineer with early-career experience in medical devices who wants to grow into deeper validation responsibilities.

Key Responsibilities

Execute validation activities under senior guidance (protocol execution, data collection, report review).

Support daily quality operations:

Nonconformances, excursions, and product impact assessments

Sorting/rework activities

Minor updates to manufacturing procedures and inspection instructions

Participate in process PFMEA reviews and risk assessments.

Ensure adherence to manufacturing procedures by spending substantial time on the manufacturing floor.

Assist with cleanroom equipment management and preventive maintenance scheduling (PMS).

Build units (R&D or scrap) as part of hands-on training to fully understand manufacturing processes.

Support audit preparation and general QMS activities.

Required Qualifications

~3-4 years of experience in medical device manufacturing or quality engineering (flexible).

Familiarity with ISO 13485 and core QMS processes (NCs, CAPA support, document control, change control).

Strong desire to learn, be hands-on, and work in a fast-moving small-company environment.

Ability to adapt quickly when priorities shift.

Preferred Qualifications

Exposure to validation activities (process, equipment, or software).

Tissue handling or sewing experience (nice but not required).

Experience in Class III medical device manufacturing or structural heart is a plus.