Quality Systems Manager

Nihon Kohden; Irvine (CA); On-site; USD 100,000 - 145,000; Full time

Job summary

Nihon Kohden America is seeking a Quality Systems Manager to maintain a compliant QMS, drive continuous improvement, and support external audits. The role partners with cross-functional teams to resolve quality issues and enhance inspection readiness.

Responsibilities include overseeing CAPA, change and document control, metrics reviews, training, and people management. A STEM degree, 6+ years in medical device/pharma and knowledge of ISO/FDA regulations are required.

Qualifications

• Bachelor’s degree in STEM field.
• 6+ years in medical device or pharmaceutical industry.
• 2+ years of people management experience.
• Quality certifications such as CQA, CQE, CMQ/OE preferred.
• Strong knowledge of GxP, ISO 13485, ISO 14971 and FDA 21 CFR 820.
• Familiarity with Canadian Medical Devices Regulations SOR/98-282.
• Knowledge of Quality Systems Software: Configuration Management, LMS.
• Strong communication and leadership skills.

Responsibilities

• Manage Nihon Kohden America's QMS and maintain regulatory compliance.
• Oversee Internal Audit program and facilitate external audits.
• Lead CAPA and Nonconformance programs including root cause analysis.
• Oversee Change Control, Document Control, and Records Management.
• Monitor QMS performance via metrics and Management Review.
• Provide training and quality systems support across the organization.
• Lead Quality Systems personnel and manage team development.

Skills

Leadership

Regulatory knowledge

Quality systems

Communication

Strategic thinking

Education

Bachelor’s degree in STEM

CQA

CQE

CMQ/OE

Tools

Configuration Management

Learning Management Systems

Job description

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

Essential Functions and Main Duties

• Manage Nihon Kohden America's Quality Management System (QMS), ensuring ongoing effectiveness and compliance with applicable regulatory requirements, standards, and company policies and procedures.
• Manage the Internal Audit program, including audit scheduling, auditor assignments, and audit reporting. Facilitate external audits, inspections, and related compliance activities. Ensure the effective resolution of any audit findings.
• Supervise the Corrective and Preventive Action (CAPA) and Nonconformance programs, including investigation and root cause analysis, risk assessment, action plan creation and implementation, effectiveness verification, and timely closure.
• Oversee Change Control, Document Control, and Records Management processes to ensure the appropriate review, approval, implementation, retention, and maintenance of controlled documentation and quality records in accordance with regulatory and company requirements.
• 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 ensure effective implementation of quality system requirements and compliance initiatives. 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 accountable team members to meet department deliverables and responsibilities. Complete company people management requirements. Exhibit manager competencies.
• Support batch record review and approval as needed.
• Adhere to all company policies, procedures, and business ethics codes.
• Duties may be modified or assigned at any time based on business need.

Qualifications

Education / Certification / Experience Required

• Bachelor’s degree in a Science, Technology, Engineering, Mathematics (STEM) field or related discipline.
• 6+ years of experience in the medical device or pharmaceutical industry.
• 2+ years of experience of people management experience, including driving results through others, leading teams or projects, and providing training.
• Quality certifications preferred (CQA, CQE, CMQ/OE).
• Strong knowledge of GxP, ISO 13485, ISO 14971, and FDA 21 CFR 820.
• Able to apply Canadian Medical Devices Regulations SOR/98-282.
• Knowledge of Quality Systems Software: Configuration Management / Learning Management Systems.
• Solid knowledge of FDA regulations and interpretation of FDA regulations, guidelines and policy statements.
• Level and compensation depend on location, experience, education and skills.
• Strong knowledge of quality systems, ISO standards, FDA regulations and expectations.
• Demonstrated ability to successfully interact with external agencies and notified bodies.
• Strong communication skills and ability to work closely with people at all levels of the organization.
• Good conceptual, analytical, problem solving, and organizational skills, including demonstrated prior accomplishments
• Ability to think strategically and bring a high level of inventiveness to the organization.
• Flexible mindset and ability to adapt to a rapidly changing environment.
• Well-organized and accustomed to maintaining excellent records.
• Must be able to communicate verbally and in writing, and to receive and understand verbal and written instructions in English.
• Able to work effectively both independently and in a collaborative team environment.

Compensation

The anticipated range for this position is $100,000 to $145,000. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, experience and location.

Perks and Benefits

Visit our Career page to learn more about Perks & Benefits and working at Nihon Kohden America

Working Conditions

Schedule: The regular hours for this full-time position are 8:00 a.m. to 5:00 p.m., Monday-Friday, unless otherwise stated by the department manager. Holiday, weekend, and evening work hours may be required. Regular hours may vary due to the needs of the organization or department and are subject to change at any time at the Company's discretion.

Physical: Generally, may require some reaching, bending, stooping, squatting, crawling, kneeling, pushing, pulling, lifting, carrying up to 25 pounds, finger dexterity, repetitive motions, standing, walking, sitting, hearing, visual acuity, color vision. More specific details may be provided as needed or requested. Reasonable accommodation may be requested by contacting Human Resources.

Travel: Minimal

Access to Customer Sites: Not Required

Nihon Kohden America is committed to maintaining a professional and respectful workplace free from discrimination, harassment, and retaliation and welcomes all qualified candidates to apply. Employment decisions are based on qualifications, experience, and business needs, without regard to legally protected characteristics. This policy applies to all employment actions, including recruitment, hiring, promotion, compensation, training, and other workplace practices.

Nihon Kohden America complies with all applicable federal, state, and local laws regarding equal employment opportunity. Employees and applicants will not be subject to harassment or retaliation for asserting their legal rights. Questions or concerns regarding this policy may be directed to Human Resources at [e-mail] .