Senior Quality Leader, Medical Devices & Compliance

Accordance Search Group; Vista (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Accordance Search Group is seeking an experienced Quality Manager in California to lead and strengthen Quality Systems within a growing medical device organization. This hands-on role works cross-functionally to improve product quality and regulatory compliance.

The position focuses on maintaining and improving the QMS, collaborating with Operations, Engineering, R&D, and Regulatory Affairs, and driving CAPA, audits, and supplier quality initiatives to support ongoing business performance.

Qualifications

• Bachelor's degree in Engineering, Science, Quality, or a related discipline preferred.
• 5+ years of progressive Quality experience within the medical device industry.
• Prior supervisory and management experience with responsibility for developing teams, managing performance, and leading quality initiatives.
• Strong knowledge of FDA Quality System requirements and ISO 13485.
• Experience with CAPA, nonconformances, audits, supplier quality, and quality systems.
• Experience working in a regulated medical device manufacturing environment.
• Strong problem-solving and root-cause analysis skills.
• Excellent communication and interpersonal skills.
• Ability to work effectively across Engineering, Manufacturing, R&D, Regulatory, and Operations.
• Hands-on, collaborative leadership style with the ability to balance strategic thinking with day-to-day execution.

Responsibilities

• Lead and manage day-to-day Quality activities and Quality Systems.
• Maintain compliance with FDA, ISO 13485, and other medical device regulatory requirements.
• Manage and continuously improve the Quality Management System (QMS).
• Oversee CAPA, nonconformances, deviations, complaints, and corrective/preventive actions.
• Lead internal and external audits, including preparation, execution, and follow-up.
• Support supplier quality activities, including supplier qualification and corrective actions.
• Partner with Engineering and Operations on design changes and process improvements.
• Review and approve quality-related documentation, procedures, reports, and records.
• Establish and monitor Quality metrics and identify opportunities for improvement.
• Investigate root causes of quality issues and drive corrective actions.
• Provide Quality guidance and training across the organization.
• Work with Regulatory Affairs to align Quality with regulatory requirements.

Skills

Quality management

Regulatory knowledge

Problem-solving

Cross-functional collaboration

Leadership

Communication

Education

Bachelor's degree in Engineering/Science/Quality

Job description

Accordance Search Group is seeking an experienced Quality Manager in California to lead and strengthen Quality Systems within a growing medical device organization. This hands-on role works cross-functionally to improve product quality and regulatory compliance.

The position focuses on maintaining and improving the QMS, collaborating with Operations, Engineering, R&D, and Regulatory Affairs, and driving CAPA, audits, and supplier quality initiatives to support ongoing business performance.