Quality Systems Engineer

Posted 5 Days Ago
Be an Early Applicant
3 Locations
Hybrid
70K-93K Annually
Senior level
3D Printing • Other
The Role
As a Quality Systems Engineer, you will manage the Quality Management System, lead CAPA processes, support audits, and drive continuous improvement initiatives while ensuring compliance with global standards.
Summary Generated by Built In
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!

Proto Labs maintains ITAR-compliant operations in all of our United States based facilities.  Due to ITAR regulations, this role is only open to U.S. Citizens, lawful permanent residents (green card holders) or foreign nationals granted refugee or asylee status.  Individuals with temporary visas (e.g. E, F-1, H-1, H-2, L, B, J, TN or OPT) are not eligible for hire in this role.
 
Proto Labs, Inc. is an Equal Opportunity Employer
 
Physical Demands:
While performing the essential duties of this job, the employee is regularly required to sit; use a computer keyboard, monitor and mouse, telephone and printer; reach with hands, and arms, talk, see and hear.  The employee is occasionally required to stand, walk, stoop or kneel and must occasionally lift and/or move up to 25 pounds.
Work Environment:
Indoors (A/C); nonsmoking; the majority of this job function is performed in an office setting requiring normal safety precautions. However, there may be job duties that require the employee to spend time in the manufacturing areas exposed to machinery and noise; eye protection occasionally required. Occasionally works in outside weather conditions. Occasionally works near moving mechanical parts and in high, precarious places and is occasionally exposed to wet and/or humid conditions, fumes or airborne particles, toxic or caustic chemicals, risk of electrical shock and vibration. The noise level in the work environment is usually quiet to moderate.
  

Skills Required

  • 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
  • Hands-on experience with CAPA processes and root cause analysis
  • Hands-on experience with 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
  • 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

Protolabs Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Protolabs and has not been reviewed or approved by Protolabs.

  • Healthcare Strength Medical, dental, and vision options are broadly available and described as good to excellent. Additional protections like short- and long-term disability and life insurance bolster the overall package.
  • Leave & Time Off Breadth A starting PTO allotment plus paid holidays, along with added wellness and volunteer time, is emphasized, with some roles noting PTO growth over tenure. Paid caregiver leave appears in postings and supports flexibility for life events.
  • Retirement Support A 401(k) with company match and immediate vesting is offered, supporting long-term savings. This foundation is frequently cited alongside core financial benefits as a strong element of total rewards.

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The Company
HQ: Maple Plain, MN
1,085 Employees

What We Do

Protolabs is the world's fastest digital manufacturing source for rapid prototyping and on-demand production. The technology-enabled company produces custom parts and assemblies in as fast as 1 day with automated 3D printing, CNC machining, sheet metal fabrication, and injection molding processes. Our digital approach to manufacturing enables accelerated time to market, reduces development and production costs, and minimizes risk throughout the product life cycle. 3D Printing Our 3D printing service offers a wide selection of materials and technologies to create prototypes and end-use parts with complex geometries and detailed features. With tight process controls, careful design reviews, and extensive quality monitoring, we ensure precise and repeatable 3D-printed parts, every time. CNC Machining We use 3- and 5-axis milling along with turning to machine parts from commercial-grade plastics and metals. Our online quoting system and automated manufacturing process enable us to ship parts within 24 hours, helping customers accelerate development and reduce time to market. Sheet Metal Fabrication Protolabs is an industry leader in quick-turn sheet metal parts for both prototyping and low-volume production. Our digital approach to manufacturing enables us to fabricate sheet metal parts in as fast as 5 days. Additionally, we can support our customers’ development efforts with component assemblies, several finish options, and screen printing. Injection Molding Our injection molding service offers two options—prototyping and on-demand manufacturing—which provide customers a tooling solution that aligns with their project’s requirements. It’s used for quick-turn prototyping, bridge tooling, and low-volume production of up to 10,000+ parts in 15 days or less.

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