Posted 23 days ago

Quality Systems Engineer

PlymouthHybridFull-time

AI Summary

Quality Systems Engineer responsible for managing and improving the QMS, driving CAPA, audits, and cross-functional quality initiatives to ensure compliance with ISO 9001, ISO 13485, and AS9100.

About this role

Be yourself at Protolabs

Studies have shown that women and people of color are less likely to apply to jobs unless they meet every single qualification.  We are an equal opportunity employer, and we are committed to building a diverse team that feels they are valued in the workplace.  So do you feel you do not meet every single requirement but still intrigued? We encourage you to still apply!  You can help make our company even better.  We do not discriminate based on race, color, national origin, sexual orientation, gender, age, mental or physical ability, or any way you represent yourself.  We strongly believe diversity makes for more successful teams.

Why Protolabs?

We are the leaders in digital manufacturing. We hire doers, makers, and creative thinkers who tackle our roles with an entrepreneurial spirit. Our culture is centered around meaningful work that brings new and innovative products to market at unprecedented speeds. We are a diverse team that comes from all walks of life and take pride in our team who is smart, genuine, humble, and passionate about what we do. It’s our people who fuel our creativity and make our culture feel like home.

Join our team as a Quality Systems Engineer!

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.

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.

What you Will Do

Quality Management System (Core Responsibility)

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

Additional Details

Travel: Occasional (audit-related; primarily local)

Schedule: Standard business hours

Work Environment: Combination of office and manufacturing floor

What it Takes

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

What Sets You Apart

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

What's in it for You

We offer a competitive total compensation package

In addition, we offer competitive benefits including but not limited to:

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!

Skills

5-Whys8DAS9100Audit Findings ManagementAudit PlanningCAPACAPA InvestigationCorrective ActionsCross-Functional CollaborationData AnalysisExternal AuditsFishboneInternal AuditsISO 13485ISO 9001Manufacturing QualityNonconformancesPreventive ActionsProcess ImprovementQMSQMS DocumentationQuality MetricsRegulatory ComplianceRoot-cause AnalysisSOPsTrend AnalysisWork Instructions