QMS Supervisor - Medical Devices

Overview

The Quality Management Systems (QMS) Supervisor is responsible for overseeing the development, implementation, and ongoing maintenance of the organization’s Quality Management System to ensure compliance with applicable regulatory and industry standards. This role partners with cross‑functional teams to promote a strong culture of quality, support audit readiness, and drive continuous improvement initiatives across the organization. Reporting into Quality leadership, this role is hands‑on in audit management, CAPA oversight, document control, and QMS performance monitoring, and serves as a key resource for quality training and compliance guidance.

• Own and maintain the Quality Management System structure, including policies, procedures, SOPs, and work instructions, ensuring alignment with regulatory requirements and organizational objectives
• Support and lead internal and external audits (registrar, customer, supplier, regulatory), including audit preparation, hosting, and response execution
• Lead root cause investigations for nonconformances, deviations, and customer complaints; develop, implement, and verify effective Corrective and Preventive Actions (CAPAs)
• Drive continuous improvement initiatives utilizing Lean principles, statistical tools, and data analysis to improve quality and operational efficiency
• Oversee electronic Quality Management Systems (eQMS) and document control processes to ensure accuracy, version control, and compliance
• Develop, trend, and present quality metrics and KPIs to leadership to support data‑driven decision‑making
• Deliver QMS, GMP, and compliance training to cross‑functional personnel to reinforce quality awareness and accountability
• Ensure alignment and consistency of Quality programs across the organization
• Regularly review and improve quality processes to enhance effectiveness, manage risk, and control costs

• Minimum of 5 years of experience in a Quality Management Systems or Quality Assurance leadership role within a regulated industry
• Strong working knowledge of ISO standards (ISO 13485 and/or ISO 9001) and audit processes
• Proven experience leading CAPA investigations, root cause analysis, and effectiveness checks
• Hands‑on experience administering and maintaining an electronic QMS platform
• Expertise in document control systems, change management, and training record management
• Ability to analyze quality data, identify trends, and implement sustainable corrective actions
• Excellent written and verbal communication skills, including the ability to interface with auditors, customers, and internal stakeholders
• Demonstrated ability to influence cross‑functional teams and lead through collaboration without direct authority
• Strong organizational skills with high attention to detail in regulated documentation environments

• Experience in the medical device industry
• Knowledge of FDA Quality System Regulation (QSR) and GMP requirements
• Certified Internal Auditor (ISO 13485/9001), ASQ Certified Quality Auditor (CQA), or Certified Quality Engineer (CQE)
• Lean Six Sigma Green Belt or Black Belt
• Experience supporting manufacturing, R&D, and operations teams within a compliance‑driven environment

Expert Level

This is a Permanent position based out of Baldwin, NY.

• Salary range: $95,000.00 – $ per year
• Medical, dental & vision
• Critical Illness, Accident, and Hospital coverage
• 401(k) Retirement Plan – Pre-tax and Roth contributions; employer match up to 4%
• Life Insurance
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Paid time off: 18 days PTO plus 13 holidays

Eligibility requirements apply to some benefits and may depend on job classification and length of employment. Benefits are subject to change.