Quality Engineer

We offer a comprehensive benefits package that includes medical, dental, and vision coverage, short-term and long-term disability insurance, life insurance, paid time off (PTO), paid parental leave, volunteer time off, and a Calm app membership. Our expanding wellness program supports your overall health and work-life balance.

Quality Engineer drives a proactive, data-driven quality culture by designing quality into processes—not inspecting it in after the fact. This role strengthens ISO compliance while advancing quality systems and built-in process controls, supplier integrity, and continuous improvement.

The Quality Engineer partners cross-functionally to ensure operational excellence through standardized work, statistical process control, structured audits, supplier quality management, and disciplined corrective action. This role champions accountability, real-time data visibility, and zero-error process design.

• Maintain and improve the ISO-compliant Quality Management System (QMS).
• Lead internal audits and customer audits; ensure timely closure and effectiveness verification of corrective actions.
• Support progression toward automotive standards, including PPAP, Control Plans, FMEA, and APQP methodologies.
• Understand minimum customer requirements in FDA regulated industries and ensure the QMS is built to bridge rigorous quality standards.
• Ensure documentation integrity, change control compliance, and standardized work across critical processes.

• Integrate quality at every stage using SPC, critical control points, in-line verification, and process validation techniques.
• Design and validate test methods (Gage R&R, correlation, progression studies).
• Analyze historical performance data to drive proactive specification improvements and reduce variability.
• Support mistake-proofing, digital verification, and structured process controls to prevent defects before they occur.

• Lead root cause investigations for internal failures and customer issues using structured problem-solving methodologies.
• Drive corrective and preventive actions with effectiveness monitoring.
• Build trend analysis, predictive insights, and performance dashboards to proactively identify risk.
• Lead quality improvement initiatives that reduce waste, variation, and cycle time while improving customer satisfaction.
• Support cross-functional Kaizen and process optimization initiatives.
• Conduct supplier audits (paper and on-site) and manage supplier performance metrics.
• Ensure raw material verification, traceability, and supplier qualification standards.
• Partner with Supply Chain and Operations to prevent defects at the source.

• Support customer audits, quality agreements, and documentation requests.
• Maintain audit-ready documentation and performance metrics at all times.
• Ensure quality standards meet or exceed customer expectations.

• Audit-ready at all times with zero major findings.
• Reduction in internal failures and customer complaints year-over-year.
• Strong supplier performance and measurable reduction in incoming defects.
• Quality metrics visible, understood, and owned by operations teams.
• Continuous improvement initiatives completed on time with measurable impact.
• Statistical Process Control (SPC) & data analysis
• Root Cause Analysis (5-Why, Fishbone, etc.)
• ISO 9001 required, IATF 16949 preferred
• APQP, PPAP, Control Plans, FMEA
• Chemical experience/background
• Audit leadership (internal & external)
• Process validation & test method development
• Lean principles & waste elimination
• Cross-functional collaboration
• Bachelor’s degree in chemistry or biology

This position requires 25% Travel domestically and internationally.

Compensation to increase based on years of experience and related industry experience.