Quality Engineer, Site Lead

About the role

The Quality Site Lead is responsible for the full range of Quality Engineering support, including quality systems, process improvement, validation, CAPA, auditing, risk assessment, training, and new product introduction support across the Elastomer Chicago manufacturing site. This role has primary ownership of ISO 9001 compliance and supports ISO 13485 medical device silicone operations as needed.

Responsibilities

• Develop, maintain, and execute quality procedures and work instructions to streamline processes and ensure compliance with FDA regulations, ISO standards, and other applicable regulatory requirements.
• Oversee the development, management, maintenance, and effectiveness of the Elastomer BU Quality Management System, including ISO 9001 and ISO 13485 compliance.
• Serve as Management Representative for the Elastomer BU Chicago site.
• Ensure all SOPs and process documentation are created in accordance with the QMS and partner with departments to ensure effectiveness.
• Ensure document control and revision control activities are maintained in compliance with QMS and regulatory requirements.
• Responsible for ensuring all cleanroom requirements are met, as applicable.
• Host customer and registrar audits and coordinate or perform internal quality and supplier audits as needed.
• Lead and/or support internal and external CAPAs, NCRs, and customer complaints, including investigation, root cause analysis, corrective actions, and related documentation.
• Change Control, Documentation, and Product Release:
• Review and assess change requests to ensure proper evaluation of impact on product quality, processes, and regulatory compliance.
• Manage customer-submitted change requests through completion.
• Review and approve engineering documentation, including validation protocols/reports, sample run requests, and manufacturing procedures, ensuring adherence to customer and regulatory requirements.
• Ensure all products conform to validated processes and DMRs; perform lot release and related quality functions.
• Production Quality, Process Control, and Continuous Improvement:
• Assure reliability and consistency of production by monitoring processes and final output.
• Leverage ISO 9001 continuous improvement principles to improve process efficiency and effectiveness.
• Monitor key quality metrics and provide regular reporting to leadership.
• Supplier Quality And Compliance:
• Collaborate with Purchasing to co-manage the Approved Supplier List and evaluate suppliers to ensure product compliance.
• Monitor supplier performance and rate suppliers through scorecard ratings.
• Calibration, Preventive Maintenance, and Resource Planning:
• Provide oversight of the calibration and preventive maintenance programs to ensure compliance.
• Collaborate with cross-functional teams to identify equipment, testing, and resource needs for new or existing products, and communicate requirements to leadership.
• Team Leadership, Training, and Talent Management:
• Achieve quality assurance human resource objectives by recruiting, selecting, orienting, training, scheduling, coaching, counseling, and disciplining employees.
• Communicate job expectations and lead team talent and performance management processes.
• Conduct employee training sessions, as applicable.
• Professional Development:
• Maintain current quality management knowledge by studying industry trends, participating in educational opportunities, reading professional publications, and engaging in professional organizations and networking opportunities.

Requirements

• Bachelor’s degree ideally in industrial, mechanical / manufacturing engineering or similar field.
• 5+ years of significant professional experience in continuous quality improvement with progressive scope and responsibility.
• 4+ years experience working within an ISO 9001 quality management system, including quality procedures, documentation, audits, corrective actions, and continuous improvement activities.
• 3+ years leading teams, ideally in a quality manufacturing environment with proven experience with Good Manufacturing Practices.
• 2+ years experience with statistical tools, data analysis, SPC, MSA, GR&R, process validation, IQ/OQ/PQ, and root cause analysis.

Core Competencies

• Regulatory Quality Leadership: Ability to interpret quality system requirements, maintain audit-ready processes, and guide site compliance in a regulated manufacturing environment.
• Manufacturing Quality Problem Solving: Strong ability to investigate issues, analyze process variation, identify root cause, and drive practical corrective actions that improve product quality and process performance.
• Cross-Functional Execution: Ability to work effectively across Quality, Operations, Engineering, Purchasing, and leadership teams to align priorities, resolve issues, and support production and NPI needs.
• Team Leadership & Quality Culture: Ability to lead cross-functional teams, drive issue resolution, train, coach, and hold quality team members accountable while reinforcing a culture of compliance, ownership, and continuous improvement.
• Quality Systems, Data & Reporting Tools: Proficient in Microsoft Office and able to use quality data, documentation, reports, metrics, and system tools to track performance, support audits, manage corrective actions, and communicate quality trends to leadership.

Preferences

• Advanced degree, Engineering degree, or another technical field.
• Experience working in Master Control QMS System.
• Continuous quality improvement experience in one or more medical product environments.
• Experience working within an ISO 13485 quality management system, including medical device documentation, audit readiness, CAPA, and regulatory compliance.
• Experience in silicone or rubber molding, including LSR, compression, or transfer molding.
• Experience supporting medical device OEM customers.
• Familiarity with FDA 21 CFR 820 and risk management, including ISO 14971.