Quality Systems Engineer
Protolabs
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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
- 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
Quality Management System (Core Responsibility)
Corrective Actions & Problem Solving
Audit Management & Compliance
Metrics & Continuous Improvement
Cross-Functional Collaboration
Additional Details
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!
Compensation (from employer):
69500–92700 USD per year
Summary
Manage, improve, and ensure compliance of quality management systems in manufacturing environment.
Job title
Quality Systems Engineer
Experience level
7–10+ years
Minimum experience
7+ years exp
Industry
manufacturing
Location requirements
Hybrid role based in Minnesota, remote Mon/Fri, onsite Tue-Thu.
Salary
69500–92700 USD per year
Management role
No
Required skills
Preferred skills
Specializations
Structured locations inferred from the posting.
Plymouth, MN, USA