Quality Systems Engineer

Protolabs

Quality Systems Engineer driving improvement and compliance for quality management systems at Protolabs. Join a diverse team in digital manufacturing with a hybrid work environment.

Posted 5/14/2026full-timePlymouth • Minnesota • 🇺🇸 United StatesSeniorLead💰 $69,500 - $92,700 per yearWebsite

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

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

Benefits

Comp & perks

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
You will receive PTO + Wellness Hours + Holiday Pay + Volunteer Hours
401k with company match and immediate vest
Employee Stock Purchase Program with a 15% discount
And More!

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

ISO 9001ISO 13485AS9100CAPA processesroot cause analysis5 WhysFishbone8Dquality metricsdata analysis

Soft Skills

analytical skillsproblem-solving skillscommunication skillscross-functional collaborationproactive mindsetownership mindsetability to manage multiple prioritiescomfort with ambiguityinfluencing skillssystems thinking