Quality Management System and Services Lead

Role Purpose

The QMS & Service Supervisor is responsible for supervising a team that supports, maintains, and continuously improves the Quality Management System (QMS). This role ensures effective execution of key quality system processes including document control, records management, EtQ administration, change management, training, CAPA, and Management Review. The supervisor ensures compliance with ISO 13485, ISO 9001, and applicable regulatory requirements while fostering a culture of quality, compliance, and continuous improvement. This position works closely with other functions within the organization (Manufacturing, R&D, Engineering, Procurement, Supplier Management, and Business Operations) to ensure adherence to standardized procedures, to ensure a life cycle management approach for Corning Life Science. 

Key Responsibilities

As the QMS & Service Supervisor, the incumbent will lead and oversee a portion of the Quality organization while fulfilling the following responsibilities:

• Supervise and coordinate a team responsible for core QMS and quality service activities, ensuring compliance with ISO 13485, ISO 9001, and applicable regulatory requirements.
• Act as process owner or process lead for Quality System elements including:
• Document Control
• Records Management
• EtQ administration
• Change Management
• Training and competency management
• Corrective and Preventive Action (CAPA)
• Management Review support
• Ensure QMS processes are established, implemented, maintained, and effective in accordance with ISO and company requirements.
• Lead daily execution and continuous improvement of QMS processes to ensure consistency, compliance, and efficiency across the organization.
• Supervise document control activities, ensuring procedures, work instructions, and records are accurate, current, approved, and retained per defined requirements.
• Oversee records management practices to ensure integrity, traceability, retention, and availability of quality records.
• Serve as primary or delegated administrator for EtQ modules related to document control, training, change management, and CAPA; provide user support and coordination with IT and Quality leadership.
• Supervise change management activities, ensuring changes are evaluated, approved, implemented, communicated, and verified for effectiveness.
• Ensure training requirements are defined, assigned, completed, and documented; monitor training effectiveness and compliance metrics.
• Oversee the CAPA process, ensuring timely investigation, root cause analysis, implementation, and effectiveness verification in alignment with ISO 13485 and ISO 9001.
• Coordinate preparation, execution, and follow‑up of Division Management Review inputs, outputs, and action items and ensure proper escalation of systematic issues which may occur across the manufacturing facilities.
• Track and report QMS performance metrics including training compliance, CAPA status, document currency, and change management effectiveness.
• Support internal, customer, certification body, and regulatory audits by providing QMS documentation, records, and process expertise.
• Review and maintain Standard Operating Procedures (SOPs) and work instructions related to QMS and quality service processes.
• Identify opportunities for system improvements, standardization, and automation to improve QMS effectiveness and efficiency.
• Ensure quality decisions are data‑driven and aligned with applicable data integrity principles.
• Act as a subject matter resource for QMS processes, providing guidance and coaching to internal stakeholders.
• Foster collaboration with cross‑functional teams including Operations, Engineering, Regulatory, and IT.
• Promote a culture of quality, compliance, and continuous improvement throughout the organization.
• Perform other related duties as required.

Additional Responsibilities:

• Establish and maintain a consistent and compliant approach to QMS process execution across all supported functions.
• Monitor changes to ISO standards, regulatory requirements, and industry best practices and support implementation as needed.
• Provide leadership, mentorship, and development to team members to build technical capability and engagement.
• Support inspection and audit readiness activities related to QMS processes.
• Communicate QMS performance, risks, and improvement opportunities to Quality leadership.
• Strong working knowledge of ISO 13485 and ISO 9001 requirements related to:
• Experience administering and supporting eQMS platforms (EtQ preferred).
• Strong organizational, time management, and prioritization skills.
• Ability to analyze data and metrics to evaluate QMS performance and effectiveness.
• Effective written and verbal communication skills.
• Ability to lead, coach, and develop team members.
• Ability to work independently while coordinating with cross‑functional stakeholders.
• Strong attention to detail with a practical, solutions‑oriented mindset.
• Ability to manage multiple priorities in a regulated environment.

Experiences/Education - Required

• Bachelor’s degree in engineering, life sciences, or a related technical discipline.
• Minimum of 5 years of experience in a quality, quality systems, or regulated manufacturing environment.
• Demonstrated experience with ISO 9001 and/or ISO 13485 Quality Management Systems.
• Prior experience supervising or leading quality or technical staff.
• Hands on experience with electronic Quality Management Systems (eQMS), preferably EtQ.
• Working knowledge of document control, training systems, CAPA, and change management processes.

Experiences/Education - Desired

• Experience in medical device, life sciences, or regulated manufacturing environments.
• Experience supporting external audits (ISO, customer, regulatory).
• ASQ or other quality‑related certification.