Quality Systems Engineer
Listed on 2026-07-01
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Quality Assurance - QA/QC
Regulatory Compliance Specialist
Join Our Team as a Quality Systems Engineer!
This is a fixed hybrid role (onsite Tuesday-Thursday & 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.
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
- 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
- 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!
$69,500 - $92,700 a year Protolabs offers a competitive total rewards package, and compensation mix vary based on position, such as base wage, as well as other earnings including incentives and commissions. Actual pay…
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