Quality Systems Engineer

Job Description 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 proceduresIdentify gaps or conflicts between SOPs, work instructions, and regulatory requirements—then drive resolutionSupport and enhance QMS processes to enable scalability during rapid business growthCorrective Actions & Problem Solving Lead and manage corrective and preventive actions (CAPA) from investigation through effectiveness verificationConduct root cause analysis using structured methodologies (e.g., 5 Whys, Fishbone, 8D)Partner cross-functionally to resolve quality issues and drive sustainable solutionsAudit Management & Compliance Support planning, execution, and follow-up of internal, external, and customer auditsPrepare documentation, coordinate audit activities, and ensure timely closure of findingsProgress toward independently leading audits and audit programsMetrics & 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 improvementsDrive continuous improvement initiatives across processes and systemsCross-Functional Collaboration Work closely with internal stakeholders to support quality initiatives and resolve issuesPartner with Quality team members and broader engineering/manufacturing teamsContribute to building a proactive, problem-solving quality cultureAdditional Details Travel: Occasional (audit-related; primarily local)Schedule: Standard business hoursWork Environment: Combination of office and manufacturing floorWhat it Takes Bachelor's degree in Engineering, Science, or related field or equivalent experience~7–10+ years of experience working within a Quality Management SystemHands-on experience with: ISO 9001, ISO 13485, and/or AS9100CAPA processes and root cause analysisInternal or external auditsStrong analytical and problem-solving skillsAbility to manage multiple priorities in a fast-paced environmentStrong communication skills and cross-functional collaboration experienceSelf-starter with a proactive, ownership mindsetComfortable working in ambiguity and driving structure where neededStrong systems thinker who can connect process, compliance, and business impactConfident communicator who can influence across teamsWhat Sets You Apart ASQ Certification (e.g., CQE, Certified Auditor)Experience in manufacturing or regulated industriesExperience developing QMS metrics and performing trend analysisExperience scaling or improving quality systems in a growing organizationWhat's in it for You We offer a competitive total compensation packageIn addition, we offer competitive benefits including but not limited to: Health Insurance: Traditional OR High Deductible planFlexible Spending AccountsHealth Savings Account (including employer contributions)Dental and VisionBasic and Supplemental Life InsuranceShort-Term and Long-Term DisabilityPaid caregiver leaveYou will receive PTO + Wellness Hours + Holiday Pay + Volunteer Hours401k with company match and immediate vestEmployee Stock Purchase Program with a 15% discountAnd More!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 offered will vary depending on multiple factors which may include, without limitation, job function, work experience, specialized skills, training, education, and certifications. 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.We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. 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