Quality Manager
$125,000–$140,000 year
On-siteSan Diego, California, United States
Job Summary
Lead Quality Operations and the Quality Management System (QMS) for the San Diego site, ensuring compliance with regulatory, customer, and business requirements. Develop, implement, and maintain quality systems, procedures, and metrics to drive continuous improvement and risk management initiatives. Manage CAPA, nonconformances, deviations, complaints, and change controls while leading internal, supplier, and regulatory audit programs. Provide leadership, coaching, and performance management for Quality Assurance and Quality Control teams, establishing quality objectives aligned with business goals. Partner with cross-functional teams to integrate quality requirements throughout the product lifecycle and maintain an effective supplier quality management program.
Required Qualifications
- Bachelor's degree in engineering, Manufacturing, Quality, or a related field
- 5-7 years of experience in Engineering and/or Quality, preferably in a medical device industry
- Experience with quality risk management principles and methodologies within a regulated manufacturing environment
- Demonstrated success leading teams, driving change, and improving quality, compliance, and business performance through continuous improvement initiatives
- Demonstrated expertise in manufacturing processes, quality systems, inspection methods, root cause analysis, nonconformance management, and CAPA processes within a regulated manufacturing environment
- Proficient in MS 365 applications
- Experience utilizing ERP/MRP systems, electronic Quality Management Systems (eQMS), and data analytics and reporting tools to monitor quality performance, compliance, and continuous improvement initiatives
- Ability to work effectively in both office and manufacturing environments, including prolonged periods of sitting, standing, walking, computer use, visual inspection activities, occasional lifting of up to 25 pounds
- Must be able to lift up to 25 pounds
Desired Qualifications
- Minimum of 3 years of experience in a supervisory or management role
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