Sr. Qa Manager Jobs

Our client is seeking a Sr. QA Manager in San Diego, CA!

Our client is a medical device company seeking a highly skilled and experienced QA Manager to lead their team and oversee Quality processes. The ideal candidate will have a strong background in quality assurance, preferably in the medical device industry, and be responsible for ensuring compliance with quality policies and procedures.

Specific Responsibilities:

• Lead and oversee the Non-Conformance Reports (NCRs), ensuring timely identification and resolution of quality issues, and tracking and reporting of corrective actions
• Plan, coordinate, and execute internal and external audits, including supplier audits, to ensure compliance
• Oversee and manage the Management Review process, including the preparation of repots and presentations for senior management and other stakeholders
• Lead and oversee the Corrective and Preventative Actions (CAPAs) processes, ensuring timely identification and resolution of quality issues, and tracking and reporting of corrective actions
• Manage the Change Control process, including the review and approval of change requests and ensuring all changes are properly documented and implemented
• Manage and maintain the Document Control system, ensuring all documents are current, accurate, and compliant with requirements and policies
• Manage the Supplier Management process, including supplier selection, qualification, monitoring, and performance evaluation, to ensure the quality of raw materials, components, and services

Qualifications:

• Experience managing Document Control, NCRs, Audits, Management Review, CAPAs, Change Control, and Supplier Management processes
• Strong communication and interpersonal skills, with the ability to interact effectively with cross-functional teams and external stakeholders
• Knowledge of FDA regulations and ISO standards related to medical devices
• 7+ years of experience in quality assurance, preferably in the medical device industry
• Strong leadership and management skills, with the ability to lead and motivate a team to achieve goals and objectives
• Bachelor's degree in related field