Quality Manager

Quality Manager, Medical Device, San Diego, CA. $140,000-$145,000 Are you a hands-on Quality leader with medical device or diagnostics experience who knows how to build teams, strengthen quality systems, and drive change? Our client, an innovative medical technology manufacturer, is seeking a Quality Manager to lead a critical function during a period of transformation, with the opportunity to help elevate the site from ISO 9001 to ISO 13485 standards.

Who you are:

• Bachelor's degree in Engineering, Manufacturing, Quality, or a related field.
• 5+ years of experience in Engineering and/or Quality within a regulated manufacturing environment, preferably medical devices or diagnostics.
• Experience overseeing both Quality Assurance (QA) and Quality Control (QC) functions.
• Strong expertise in quality systems, risk management, CAPA, nonconformance management, root cause analysis, supplier quality, and audit readiness.
• Proven leadership experience developing teams, driving change, and improving quality and compliance performance.

What you'll do:

• Lead Quality Operations and the Quality Management System (QMS), ensuring compliance with regulatory, customer, and business requirements.
• Manage and develop Quality Assurance, Quality Control, and Quality Engineering teams while supporting quality activities on the production floor.
• Manage up to 24 people on Quality team.
• Drive the site's quality transformation initiatives, including strengthening systems, processes, and readiness for ISO 13485 implementation.
• Oversee CAPA, deviations, complaints, nonconformances, change controls, supplier quality, and quality risk management programs.
• Lead audits, inspections, management reviews, and cross-functional continuous improvement initiatives to enhance quality performance and customer satisfaction.

Why work here:

• High-visibility leadership role with significant impact across the organization.
• Opportunity to rebuild and strengthen a quality organization during a transformational period.
• Direct influence on the site's transition from ISO 9001 to ISO 13485.
• Strong benefits package, including employer 401(k) contributions and matching that can total approximately 10%.

What does this position pay? Compensation is determined by several factors which may include skillset, experience level, and education.

The expected range for this role is $140,000-$145,000 per year. Please note this range is an estimate and actual pay may vary based on qualifications and experience.

What's next? Please email your resume to [email protected] if you're excited to explore this opportunity with our client.

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