Quality Assurance Manager

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

Our client is seeking an experienced Quality Manager to lead and strengthen Quality Systems within a growing medical device organization. This is an excellent opportunity for a hands‑on Quality professional who enjoys working cross-functionally and making a meaningful impact on product quality, regulatory compliance, and overall business performance.

The Quality Manager will be responsible for maintaining and continuously improving the company's Quality Management System while partnering closely with Operations, Engineering, R&D, Regulatory Affairs, and other functional teams.

Key Responsibilities

• Lead and manage day-to-day Quality activities and Quality Systems.
• Maintain compliance with applicable 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, monitoring, and corrective actions.
• Partner with Engineering and Operations on design changes, process improvements, validation, and product quality issues.
• Review and approve quality‑related documentation, procedures, reports, and records.
• Establish and monitor Quality metrics and identify opportunities for continuous improvement.
• Investigate root causes of quality issues and drive effective corrective actions.
• Provide Quality guidance and training across the organization.
• Work closely with Regulatory Affairs to ensure alignment between Quality and regulatory requirements.
• Foster a culture of quality, accountability, and continuous improvement.

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 teamsm 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.

Preferred Experience

• Experience with FDA inspections and/or notified body audits.
• Experience with risk management and ISO 14971.
• Experience supporting product development and design controls.
• Experience with process validation and/or equipment qualification.
• Experience implementing or improving an electronic QMS.
• ASQ certification (CQE, CQA, or similar) is a plus.