Quality Systems Engineer

About the role

This is a fixed hybrid role (onsite Tuesday-Thursyday & remote Mon/Fri) based in one of our Minnesota locations: Plymouth, Rosemount, or Maple Plain. Protolabs is seeking a Quality Systems Engineer to help build, scale, and continuously improve our Quality Management System (QMS) as we grow our leadership in digital manufacturing.

Responsibilities

• Manage, maintain, and improve the company’s QMS in alignment with ISO 9001, ISO 13485, AS9100, and internal procedures
• Identify gaps or conflicts between SOPs, work instructions, and regulatory requirements—then drive resolution
• Support and enhance QMS processes to enable scalability during rapid business growth
• Corrective Actions & Problem Solving: Lead and manage corrective and preventive actions (CAPA) from investigation through effectiveness verification
• Conduct root cause analysis using structured methodologies (e.g., 5 Whys, Fishbone, 8D)
• Partner cross-functionally to resolve quality issues and drive sustainable solutions
• Audit Management & Compliance: Support planning, execution, and follow-up of internal, external, and customer audits
• Prepare documentation, coordinate audit activities, and ensure timely closure of findings
• Progress toward independently leading audits and audit programs
• Metrics & Continuous Improvement: Develop, track, and analyze quality metrics (e.g., CAPA cycle time, audit findings, nonconformances)
• Use data and trend analysis to assess QMS effectiveness and recommend improvements
• Drive continuous improvement initiatives across processes and systems
• Cross-Functional Collaboration: Work closely with internal stakeholders to support quality initiatives and resolve issues
• Partner with Quality team members and broader engineering/manufacturing teams
• Contribute to building a proactive, problem-solving quality culture

Requirements

• Bachelor’s degree in Engineering, Science, or related field or equivalent experience
• 7–10+ years of experience working within a Quality Management System
• Hands-on experience with: ISO 9001, ISO 13485, and/or AS9100, CAPA processes and root cause analysis, Internal or external audits
• Strong analytical and problem-solving skills
• Ability to manage multiple priorities in a fast-paced environment
• Strong communication skills and cross-functional collaboration experience
• Self-starter with a proactive, ownership mindset
• Comfortable working in ambiguity and driving structure where needed
• Strong systems thinker who can connect process, compliance, and business impact
• Confident communicator who can influence across teams

Qualifications

• ASQ Certification (e.g., CQE, Certified Auditor)
• Experience in manufacturing or regulated industries
• Experience developing QMS metrics and performing trend analysis
• Experience scaling or improving quality systems in a growing organization

Skills

• Communication skills
• Problem-solving skills
• Systems thinking
• Ownership mindset
• Adaptability

Benefits

• Competitive total compensation package
• Health Insurance: Traditional OR High Deductible plan
• Flexible Spending Accounts
• Health Savings Account (including employer contributions)
• Dental and Vision
• Basic and Supplemental Life Insurance
• Short-Term and Long-Term Disability
• Paid caregiver leave
• PTO + Wellness Hours + Holiday Pay + Volunteer Hours
• 401k with company match and immediate vest
• Employee Stock Purchase Program with a 15% discount
• Additional benefits may include:

Pay

$69,500 - $92,700 a year

Schedule

Standard business hours