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Group: JOBS 2.0: Job Search Career Networking Staffing. Post Resume -Get Paid by Employers at Resumark .com Subject: I'm hiring at DIRECTOR OF RA/QA - awesome culture - check out this job Matt Turner 858.356.6772 posted a job: I'm hiring at DIRECTOR OF RA/QA - awesome culture - check out this job "Now Hiring: DIRECTOR OF RA/QA in Huntington Beach, CA DIRECTOR OF RA/QA Simply Biotech specializes in recruiting exclusively for the medical device and biotech industry. We are currently seeking a Director of RA/QA for a growing Medical Device Company. This position is based in Orange County, CA.   Reporting to the COO, the Director is responsible for all polices and activities in the areas of medical device, quality, compliance, and submission. The Director ensures that the company operates according to its quality system to provide products that meet customer requirements, maintains compliance with applicable regulations, and maintains compliance with regulatory agencies in accordance with applicable state, federal and international laws.   Other responsibilities include: *  Provides leadership in directing companywide quality assurance and regulatory processes *  Manages all aspects of the Quality System and processes to ensure compliance with Quality System Regulations, International Standards supporting regulatory and certification requirements *  Prepares and/or oversees submissions to FDA and foreign agencies, including 510(k) applications and international product registrations *  Ensures continuous update and maintenance of RA/QA files. *  Administers and oversees regulatory training programs. *  Works with contract manufacturers to improve quality through prequalification reviews and on-going oversight and audits. *  Generates periodic reports to aid management in the identification and resolution of issues and overall quality improvement efforts *  Supervises Internal Quality System Audits and ensures that corrective actions resulting from these audits are performed. *  Oversees complaint handling, medical device reporting, vigilance reporting, and label control. *  Participles in the development of a strategic plan to define the company business direction for regulated devices. *  Acts as the corporate technical expert for all regulations (FDA, CE, ISO, etc) *  Communicates with regulatory authorities to obtain timely product approvals *  Provides direction and support to Quality and Regulatory staff members. *  Manages controlled documentation to ensure conformance to standards *  Responsible for routing, tracking, and facilitating timely documentation review, approval, and implementation. *  Oversees change control processes *  Develops, implements, and adjusts, as needed, company quality strategies. * Ensures early identification of quality issues/threats affecting the development of products and identify corrective action *  Oversees all inspections and internal audits *  Monitors external regulatory developments, identifies risks and communicates potential issues to management. *  Leads a team, ensuring their growth and development and their ability to exceed stakeholder expectations. The qualified Director of RA/QA will possess the following: *  College degree or equivalent experience required, with preference to engineering or scientific disciplines. * ... http://bull.hn/l/O9DR/4"

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