Senior Quality Manager - Medical Device

Sr. Quality Manager – Medical Device

Location: Vista, CA

Industry: Medical Device

Employment Type: Full-Time

About the Opportunity

Our client is seeking an experienced Sr . 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.
• 8+ 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.