Quality Systems Engineer

Protolabs•Rosemount, MN

1d•Hybrid

About The Position

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. This is a high-impact opportunity for an experienced quality professional who thrives in a fast-paced, evolving environment and is excited to drive process improvement, support audits, and strengthen quality systems at scale. You’ll play a key role in ensuring compliance with global standards while partnering across the business to embed quality into day-to-day operations.

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

Nice To Haves

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

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
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
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
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
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