Quality Manager

Position Summary

The Quality Manager is responsible for leading, implementing, and continuously improving the organization’s Quality Management System (QMS) to ensure product quality, regulatory compliance, operational excellence, and customer satisfaction.

This is a hands‑on leadership role responsible for driving execution and delivering measurable business results. The Quality Manager works directly with Operations, Engineering, Supply Chain, and customers to solve problems, improve manufacturing processes, reduce risk, and ensure quality is built into every stage of production—not inspected into products after the fact.

The successful candidate will spend significant time on the manufacturing floor observing processes, coaching employees, leading investigations, implementing corrective actions, verifying process discipline, and ensuring sustainable improvements are achieved. Success in this role is measured by execution, accountability, improved quality performance, and customer satisfaction.

• Lead with integrity, accountability, professionalism, and sound business judgment.
• Foster a culture of ownership, process discipline, continuous improvement, and operational excellence.
• Build prevention-based quality systems that eliminate defects through robust processes, effective controls, and risk management rather than relying primarily on inspection.
• Lead by example through visible engagement on the manufacturing floor and direct involvement in solving quality and manufacturing issues.
• Hold employees and functional leaders accountable for compliance with documented processes, quality standards, and regulatory requirements.
• Develop employees through coaching, mentoring, performance management, and effective communication.
• Remain current on industry standards, quality methodologies, customer requirements, and regulatory changes.

• Quality Management System Leadership
• Lead, maintain, and continuously improve the Quality Management System (QMS) to ensure compliance with customer, regulatory, and business requirements while driving operational excellence.
• Serve as Management Representative for ISO 13485 and other applicable quality management systems.
• Ensure quality systems are effectively implemented, consistently followed, and continuously improved throughout the organization.
• Drive process discipline by ensuring quality is built into manufacturing processes rather than relying on downstream inspection.
• Operational Quality Leadership
• Spend significant time on the manufacturing floor observing operations, verifying process compliance, coaching employees, identifying risks, and driving immediate corrective action.
• Work directly with Operations and Engineering to improve manufacturing processes, reduce variation, improve yield, reduce Cost of Poor Quality (COPQ), and eliminate recurring quality issues.
• Personally lead investigations involving customer complaints, escapes, process failures, audit findings, and significant quality events.
• Challenge ineffective processes, remove barriers to quality performance, and ensure issues are resolved at their source.
• Hold functional areas accountable for sustaining process improvements and complying with quality system requirements.
• Quality Systems & Continuous Improvement
• Personally lead the organization’s CAPA process by ensuring timely containment, thorough root cause analysis, implementation of sustainable corrective actions, and verification of long‑term effectiveness.
• Lead structured problem solving using methodologies such as 8D, 5 Whys, Fishbone, PFMEA, SPC, and statistical analysis.
• Plan, conduct, and lead internal audits while personally verifying corrective actions are implemented and sustained.
• Lead Management Review activities and provide leadership with accurate quality performance metrics, emerging risks, trends, and recommended actions.
• Metrics & Business Performance
• Establish meaningful quality objectives and key performance indicators that measure process capability, customer satisfaction, Cost of Poor Quality (COPQ), scrap, rework, escapes, and operational performance.
• Routinely analyze quality and operational…