Quality Assurance Manager

Position Summary: The Quality Manager 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 Manager 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.1. Quality Management System & Compliance 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. 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. Operate as an internal escalation point, providing guidance to other members of the Quality team.2. Built-In Quality & Process Excellence 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.3. Data-Driven Problem Solving & Continuous Improvement 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.4. Supplier & Material Quality 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.5. Customer & Audit Readiness 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.6. Culture, Leadership & Accountability Champion a culture of ownership where quality is embedded in every role. Support training on quality systems, statistical tools, and standardized processes. Promote stop-work authority, proactive error prevention, and open reporting. Operate with structured project management discipline and data-backed decision making. Success Profile (What “Great” Looks Like)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.

Required Experience: Statistical Process Control (SPC) & data analysis Root Cause Analysis (5-Why, Fishbone, etc.)ISO 9001 Chemical experience/background Audit leadership (internal & external)Process validation & test method development Lean principles & waste elimination Cross-functional collaboration Strong documentation discipline Minitab experience Bachelor’s degree in chemistry or biology This position requires 25% Travel domestically and internationally Base Salary compensation to increase based upon applicable years of experience and leadership capabilities