Quality Systems Engineer

TL;DR

Quality Systems Engineer (QMS): Manage, maintain, and improve the company’s Quality Management System in alignment with ISO 9001, ISO 13485, AS9100 with an accent on compliance, scalability, and process optimization. Focus on leading CAPA processes, conducting root cause analysis using structured methodologies, supporting audits, tracking quality metrics, and driving cross-functional continuous improvements.

Location: Fixed hybrid role (onsite Tuesday-Thursday & remote Monday/Friday) based in Plymouth, MN; Rosemount, MN; or Maple Plain, MN. U.S. Citizens, lawful permanent residents (green card holders), or refugees/asylees only due to ITAR regulations. Temporary visas (E, F-1, H-1, etc.) not eligible.

Salary: $69,500 - $92,700 biweekly

Company

Leaders in digital manufacturing, hiring doers and creative thinkers to bring innovative products to market at unprecedented speeds.

What you will do

• Manage, maintain, and improve QMS aligned with ISO 9001, ISO 13485, AS9100, and internal procedures; identify and resolve gaps in SOPs and work instructions.
• Lead corrective and preventive actions (CAPA) from investigation to effectiveness verification using root cause analysis (5 Whys, Fishbone, 8D).
• Support internal, external, and customer audits: plan, execute, prepare documentation, and close findings.
• Develop, track, and analyze quality metrics (CAPA cycle time, audit findings, nonconformances) to assess effectiveness and recommend improvements.
• Collaborate cross-functionally with quality, engineering, and manufacturing teams to embed quality into operations and build a proactive culture.

Requirements

• Bachelor’s degree in Engineering, Science, or related field or equivalent experience.
• 7–10+ years experience in Quality Management Systems.
• Hands-on with ISO 9001, ISO 13485, and/or AS9100; CAPA processes and root cause analysis; internal/external audits.
• Strong analytical, problem-solving, communication, and cross-functional collaboration skills.
• Self-starter comfortable in fast-paced, ambiguous environments; systems thinker linking process, compliance, and business impact.

Nice to have

• ASQ Certification (CQE, Certified Auditor).
• Experience in manufacturing or regulated industries.
• Developing QMS metrics and trend analysis.
• Scaling or improving quality systems in growing organizations.

Culture & Benefits

• Competitive total compensation with incentives.
• Health, dental, vision insurance; HSA/FSA with employer contributions; life/disability insurance.
• PTO, wellness hours, holidays, volunteer hours, paid caregiver leave.
• 401k with company match and immediate vesting; Employee Stock Purchase Program with 15% discount.
• Diverse, entrepreneurial culture focused on meaningful work, innovation, and work-life balance.