Quality Systems Manager

Nihon Kohden America • Irvine, CA

3d

About The Position

The Quality Systems Manager ensures Nihon Kohden America's Quality Management System (QMS) remains compliant, effective, efficient, and inspection-ready through proactive monitoring, auditing, quality metric analysis, and continuous improvement. The role partners with cross-functional departments to drive compliance, resolve quality system issues, and support external audits and regulatory inspections. It requires strong leadership and project management skills, along with working knowledge of medical device quality system regulations and standards.

The manager oversees the QMS and its key processes, including internal audits, CAPA, nonconformance, change control, document control, and records management. The position monitors system performance through metrics, trending, and Management Review; prepares reports and recommendations for leadership; drives Quality Objectives and improvement initiatives; and provides training and support throughout the organization. The role also leads and develops Quality Systems personnel and supports batch record review and approval as needed.

Requirements

• Bachelor's degree in a STEM field or related discipline.
• At least 6 years of experience in the medical device or pharmaceutical industry.
• At least 2 years of people-management experience, including driving results through others, leading teams or projects, and providing training.
• Strong knowledge of GxP, ISO 13485, ISO 14971, and FDA 21 CFR 820.
• Ability to apply Canadian Medical Devices Regulations SOR/98-282.
• Solid knowledge of FDA regulations and interpretation of FDA regulations, guidelines, and policy statements.
• Knowledge of quality systems software, including Configuration Management and Learning Management Systems.
• Strong knowledge of quality systems, ISO standards, and FDA regulations and expectations.
• Demonstrated ability to interact successfully with external agencies and notified bodies.
• Strong communication skills and ability to work closely with people at all organizational levels.
• Good conceptual, analytical, problem-solving, and organizational skills, including demonstrated prior accomplishments.
• Ability to think strategically and bring inventiveness to the organization.
• Flexible mindset and ability to adapt to a rapidly changing environment.
• Well-organized and accustomed to maintaining excellent records.
• Ability to communicate verbally and in writing in English, and to receive and understand verbal and written instructions in English.
• Ability to work effectively independently and in a collaborative team environment.

Nice To Haves

• Quality certification such as CQA, CQE, or CMQ/OE.

Responsibilities

• Manage Nihon Kohden America's QMS to ensure ongoing effectiveness and compliance with applicable regulatory requirements, standards, company policies, and procedures.
• Manage the Internal Audit program, including audit scheduling, auditor assignments, and reporting.
• Facilitate external audits, inspections, and related compliance activities, and ensure audit findings are effectively resolved.
• Supervise CAPA and Nonconformance programs, including investigations, root cause analysis, risk assessment, action plans, implementation, effectiveness verification, and timely closure.
• Oversee Change Control, Document Control, and Records Management processes, ensuring controlled documentation and quality records are appropriately reviewed, approved, implemented, retained, and maintained.
• Monitor QMS performance through metrics, trending, and Management Review activities.
• Prepare quality reports and recommendations for leadership and drive initiatives to improve quality system effectiveness, efficiency, and inspection readiness.
• Drive achievement of the Quality Objectives.
• Partner with cross-functional teams to implement quality system requirements and compliance initiatives effectively.
• Provide training, consultation, and quality systems support to personnel throughout the organization.
• Lead, develop, and manage Quality Systems personnel by establishing goals, assigning responsibilities, monitoring performance, and supporting employee development and succession planning.
• Select, manage, develop, and hold team members accountable for department deliverables and responsibilities.
• Complete company people-management requirements and exhibit manager competencies.
• Support batch record review and approval as needed.
• Adhere to company policies, procedures, and business ethics codes.
• Perform other duties as assigned or modified based on business need.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager