Quality Systems Engineer

Role Overview

• 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

Requirements

• 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

Benefits

• 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!