Quality Manager (San Diego)
$140k - $145kFull-time
Proven Recruiting
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.
- 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.
- 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%.
Vacancy posted 12 hours ago
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