QMS Supervisor - Medical Devices

QMS Supervisor - Medical Devices

The Quality Management Systems (QMS) Supervisor oversees the development, implementation, and continuous improvement of the organization's Quality Management System to ensure full compliance with applicable regulatory and industry standards. This role partners closely with cross-functional teams to foster a strong culture of quality, maintain audit readiness, and drive continuous improvement initiatives across the organization. Reporting into senior Quality leadership, the QMS Supervisor plays a hands-on role in audit management, CAPA oversight, document control, and QMS performance monitoring, while serving as a key resource for quality training and compliance guidance.

Responsibilities

• Own and maintain the Quality Management System structure, including policies, procedures, standard operating procedures (SOPs), and work instructions, ensuring alignment with regulatory requirements and organizational objectives.
• Support and lead internal and external audits, including registrar, customer, supplier, and regulatory audits, covering audit preparation, hosting, and response execution.
• Lead root cause investigations for nonconformances, deviations, and customer complaints, and develop, implement, and verify effective Corrective and Preventive Actions (CAPAs).
• Drive continuous improvement initiatives using Lean principles, statistical tools, and data analysis to enhance product quality and operational efficiency.
• Oversee electronic Quality Management Systems (eQMS) and document control processes to ensure data accuracy, robust version control, and ongoing compliance.
• Develop, track, and present quality metrics and key performance indicators (KPIs) to leadership to support informed decision-making and strategic planning.
• Deliver QMS, Good Manufacturing Practice (GMP), and compliance training to cross-functional personnel to reinforce quality awareness and accountability throughout the organization.
• Ensure alignment and consistency of quality programs and processes across all relevant departments and functions.
• Regularly review, assess, and improve quality processes to enhance effectiveness, manage risk, and control costs within the quality system.
• Collaborate closely with cross-functional teams, including manufacturing, R&D, and operations, to support compliance-driven activities and initiatives.

Essential Skills

• Minimum of 5 years of experience in a Quality Management Systems or Quality Assurance leadership role within a regulated industry.
• Strong working knowledge of quality management standards and audit processes, including ISO-based quality system frameworks.
• Proven experience leading CAPA investigations, including root cause analysis, development of corrective and preventive actions, and verification of effectiveness.
• Hands-on experience administering and maintaining an electronic Quality Management System (eQMS) platform.
• Expertise in document control systems, including change management and training record management in a regulated environment.
• Ability to analyze quality data, identify trends, and implement sustainable corrective and preventive actions based on data-driven insights.
• Demonstrated experience in quality assurance for medical devices, including exposure to spine, neurology, or implantable device products.
• Experience with internal and external audits within a quality-regulated environment.
• Strong understanding of regulatory affairs and quality assurance practices in regulated industries.
• Excellent written and verbal communication skills, with the ability to interface effectively with auditors, customers, and internal stakeholders at all levels.
• Demonstrated ability to influence cross-functional teams and lead through collaboration without direct authority.
• Strong organizational skills and high attention to detail, particularly in managing regulated documentation and records.

Additional Skills & Qualifications

• Experience working in the medical device industry.
• Knowledge of FDA Quality System Regulation (QSR) and Good Manufacturing Practice (GMP) requirements.
• Certified Internal Auditor or equivalent certification in ISO-based quality management systems.
• ASQ Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE) credentials.
• Lean Six Sigma Green Belt or Black Belt certification or training.
• Experience supporting manufacturing, research and development (R&D), and operations teams within a compliance-driven environment.
• Familiarity with quality management standards such as AS9100 and ISO 9001.
• Background in quality management for specialized medical device areas such as spine, neurology, or implantable devices.

Work Environment

This role is 100% office-based in a cubicle work environment, providing a structured and professional setting focused on quality and compliance activities. The position centers on the use of electronic Quality Management Systems and other office-based tools to manage documentation, audits, metrics, and training. The work environment supports collaboration with…