US-CA-Pleasanton: Sr. Director of Quality Assurance
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please visit http://sqa.fyicenter.com
Sr. Director of Quality Assurance
* Responsible for the strategy, administration, and direction of the Quality Assurance organization.
* Directs all aspects of Quality Assurance, using a well-grounded understanding of technical, scientific and regulatory issues. Directly supervises exempt department personnel up to the director level and exercises general supervision over all employees in the Quality Assurance organization.
* Manages the operating budget for the Quality Assurance operational and engineering groups.
* Has overall responsibility for the Quality Assurance Department, including Receiving Inspection, Supplier Quality Assurance, In-Process Quality Assurance, Sustaining and New Product Development Quality Engineering, Sterility Assurance and Microbiology activities.
* Functions as an integral member of the new product development team responsible for management of all pre-clinical and clinical studies.
* Provides Quality Engineering input during the Design Control, Design Review, and Design Transfer processes through review and approval of the applicable design control documentation.
* Participates in new product development team meetings, technical design reviews, and phase gate design review meetings to contribute quality assurance requirements and considerations.
* Leads quality planning activities for new product development.
* Leads risk management activities throughout the product lifecycle, including new product development and post production risk management.
* Manages Receiving Inspection team. Coordinates and communicates with internal Supply Chain Management and Manufacturing Engineering groups and external suppliers to ensure timely corrective action when purchased goods and services do not meet requirements.
* Ensures all inspection and testing as part of product acceptance activities preformed on behalf of the company comply with internal controlled procedures, and external quality system regulations and standards.
* Works with R&D and Manufacturing Engineering to assure the effective development and qualification of inspection and test methods and equipment.
* Regularly reviews quality system standard operating procedures and work instructions, making changes as necessary to ensure compliance and efficiency Quality Assurance processes.
* Provides input to the Management Review process for systems assigned to Quality Assurance. Responds to corrective actions assigned from Management Review meetings.
* Develops, administers, and maintains quality systems required to ensure the company’s products are in compliance with quality standards as required.
* May lead FDA and other Agency factory inspections. Responds to nonconformities identified in internal and external audits, and to corrective / preventive actions assigned to Quality Assurance.
* Maintains oversight of the administration of all facets of sterility assurance and microbiology for new and current medical devices in order to assure compliance with internal and external requirements.
* May travel up to 20%.
* Bachelors of Science degree or higher required (engineering, technical, or life sciences field strongly preferred).
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