Sr Manager, Quality Assurance at Insight Global in San Diego, CA - job 2 of 2

The employer is enterprise level company in the medical device industry that develops and produces diagnostic devices. The Sr. QA Manager will support all Quality Management Systems and will provide QA expertise and support by performing a diverse set of responsibilities to develop, implement and maintain documentation compliance with the quality systems. This Manger will have 4 direct reports... and will oversee document control, product release, equipment management, and production groups. Responsibilities include managing and monitoring document control activities, batch record reviews, training, internal/external auditing, work with system users to maintain compliance of the system. Additionally, supports quality inspections and audits by third parties including regulatory bodies. Responsibilities: - Support the Sr. Director of Quality in implementation, maintenance, and compliance management of the Quality System. Act as deputy management representative - Performs QA Review for Quality System documentation including Batch Record lot release, Change Orders, CAPA, NCRs, Deviations, etc. - Develop, maintain, and report to senior management Quality Metrics for document control - Provide training, guidance and coaching to internal and external customers - Supports internal and external audits as needed - Maintain & support regulatory submissions as needed. Which may include: clinical trial documentation. Works collaboratively with Senior Management and other departmental functions such as Operations, R&D, Regulatory Affairs, Clinical, to resolve issues associated with Document Control, Quality Assurance, and Quality Systems - Compliance with established Company and departmental policies and procedures, objectives, quality assurance program, safety and environmental standards - Other duties as assigned; as emerging growth company it may be required from time to time to assist in other areas other than the area of specialty Minimum Requirements - Bachelors degree - 8 years of experience in a regulated environment - 3 years of experience managing people/teams - Experience in the medical device industry (Biotech, pharmaceutical, life science are also applicable) - Experience supporting quality for a manufacturing group - Experience in implementing quality systems and process improvements during the development, manufacture, and commercialization - Strong knowledge of ISO 13485 standards - Knowledge of other country directives and regulations is highly preferred - Experience with Document Control Systems, such as Agile, MasterControl, Etc., and electronic signature process compliant to FDAs Part 11 for electronic records Salary Range: $100K -- $150K Minimum Qualification Quality ManagementEstimated Salary: $20 to $28 per hour based on qualifications