Senior Manager of RA/QA diaDexus
THIS JOB HAS EXPIRED The Senior Manager of RA/QA is responsible for participation in the surveillance and continuous improvement of the Quality System. This position also participates in Regulatory activities concerning current products and new product development. This position provides guidance and acts as a resource to less senior quality associates concerning the implementation, monitoring and maintenance of quality assurance systems and activities. This position also acts as a resource for questions from the documentation function. All activities are to be performed in compliance with the corporate quality policy, corporate and department goals and external regulations.
The Senior Manager is expected to:
Works with Development, Manufacturing and Quality Control to develop production, inspection and testing procedures for commercial products, including documentation transferred to contract manufacturers.
Implements quality assurance and regulatory design control activities for new product development teams to achieve successful and timely product introductions. Includes participation in/as: the quality/regulatory representative, establishment of regulatory strategy and timelines, establishment of quality strategy and timelines, generation of controlled manufacturing and testing documentation, supplier and material qualification, product validation, DHF audits, establishment of performance characteristics of tests, approval of product labeling and promotional materials and other regulatory or quality related deliverables within design control regulations and procedures.
Participates in the corrective and preventive action system. Ensures input from various sources are addressed through effective root cause analysis and troubleshooting investigations in resolving and precluding product, service and quality system failures and inefficiencies.
Oversees customer complaint handling function to ensure proper and timely complaint handling, root cause identification, customer satisfaction and complaint closure. Closes complaint files. Monitors complaint review and performs trend analysis.
Ensures compliance to the review and reporting requirements of the U.S./EU Medical Device Reporting regulations (MDR and MDV) and the US/EU Corrective Action review and reporting requirements.
Participates in the internal and external audit function, helps to schedule and plans audits, conducts audits, prepares reports, and follows-up on corrective actions to ensure compliance.
Participates in the manufacturing validation program which includes the review of validation specific Plans, protocols, schedules, results and reports.
Supports and may prepare regulatory submissions both US and International.
Facilitates Risk Management processes and procedures for new product development and manufacturing validation teams.
Participates in developing training programs and provides basic QSR/GMP training to the site and to new employees.
Acts as a resource for the document control function from a process perspective. Manages documentation including electronic indexes, files and databases, master files and history records.
Issues batch record documents, assigns lot numbers, releases product, audits and maintains completed device history records, ensures product traceability and record retention.
Ensures product release is under regulatory compliance.
Serves as Management Representative with authority over and responsibility for ensuring that quality system requirements are effectively established and effectively maintained, and for reporting on the performance of the quality system to management with executive responsibility for review.
||343 Oyster Point Boulevard |
South San Francisco, CA 94080
THIS JOB HAS EXPIRED