Vice President, Quality Systems Regulatory (Medical Device)

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Location :
San Jose, California

Expiry Date :
Tue, 09 Mar 2021 23:59:59 GMT

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Description :
This_is_NOT_a_Quality_Assurance_role._It_is_a_Quality_Systems_(FDA)_and Regulatory_position. Who is VitalConnect, Inc.: VitalConnect is a medical device company designing and manufacturing state-of- the-art biosensor technology to gather, store and analyze biometric data, and associated visualization and notification software. VitalConnect s product are designed for use in a broad range of inpatient and outpatient settings, such as hospital monitoring, post-discharge care, cardiac monitoring, and pharmaceutical solutions. Our History: Headquartered in the heart of Silicon Valley, California, VitalConnect was founded in 2011 with a vision of changing the paradigm of healthcare as we know it by creating a new world of information with predictive data analytics at everyone s fingertips. Vital Connect provides physicians, nurses, and patients with an extraordinary advancement in healthcare. Never before has so much continuous monitoring of vital signs been possible in a single, small yet powerful device. VitalConnect has consolidated eight critica vital signs into one wireless biosensor. Our Purpose: Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions. We aim to lead the markets we serve by requiring the solutions we offer customers provide an improved benefit/risk profile as compared to existing standards of care; a performance threshold that by definition, guides and ensures the productive output of our engineering, business development, and clinical research efforts result in outcomes that advance the standard of care. Department: Quality/Regulatory – MEDICAL DEVICE Reports to:COO Purpose Develop, implement and lead the Company s quality, regulatory, and complian efforts aligned with the overall mission and goals of the organization and integrated with clinical, operations and marketing efforts. Serve as the company s Management Representative, and lead contact (Qualified Person) fo regulatory agencies and Notified Bodies. Responsibilities * Plan, design, and implement a comprehensive quality system that complies with relevant FDA GMP Design Control and ISO 13485 regulations appropriate for the Company s products * Lead the implementation of the QMS and work co-operatively with R&D, marketing, operations, and others within the company to drive improvements in customer satisfaction, productivity, regulatory compliance, and company efficiency * Plan, execute, and manage quality assurance systems and activities including quality engineering, product release, CAPA/Non-conforming system, complaint investigation, document control, and training systems, ensuring compliance with regulatory and company requirements * Serve as the site host during 3rd Party audits, i.e. Notified Body, FDA, and other regulatory agency compliance inspections and coordinate responses. * Maintain strong relationships with regulatory agencies, competent authorities, and standards organizations which impact the Company * Manage and maintain the internal and supplier audit system, the corrective/preventive action system, the control nonconforming material system, complaint system, document control system, and others as required * Work closely with other departments to ensure projects conform to all regulatory and quality requirements * Assure the plant is compliant with cGMP regulations and is maintained in an inspection-ready status * Implement proactive quality programs to prevent compliance problems, reduce losses, and assure timely release of products * Assist in preparation of reports, summaries, and other data to support product and establishment regulatory submissions; * Coordinate and facilitate periodic Management Review to inform management of compliance risks, improvements, and current status of the Quality System * Provide quality training to site staff and new hires in the use of the quality system and associated regulations * Ensuring the promotion and awareness of regulatory and customer requirements throughout the organization * Ensuring VitalConnect operates in compliance with state, federal, and international laws and regulations governing the manufacture and distribution of medical devices * Reviewing technical problems and procedures and recommending solutions * Ensuring representation of Quality Assurance at design and development meetings Education * Bachelor s degree preferred * Degree in life sciences or engineering preferred Experience * A minimum of 15 years experience in quality operations in the Medical Device industry and a minimum of 10 years supervisory experience. Knowledge and Training * Knowledge and competency in the application of FDA, ISO 13485, ISO 14971, MDD, MDR, and other regulatory requirements, especially in the area of Quality Systems and Design Control as applied to projects from design inception to manufacturing release, is required. * Solid understanding and relevant experience in software/hardware/ mechanical design verification and validation methods. * Ability to balance the needs of a fast-paced start-up environment with the needs for good documentation and quality control. * Experience in implementing and managing documentation/configuration control systems. * Experience with FDA/ISO design control audits. * Experience with the following techniques; Hazard Analysis, Risk Analysis, FMEA. * Quality systems implementation and maintenance experience required. * Demonstrated abilities in building and leading cross-functional/cross- site teams, time and budget management influencing and working well with others in a proactive and constructive manner, and communicating clearly, in both verbal and written forms, within all levels of the organization is required. * Experience preparing and executing training programs, internal and vendor quality auditing, and interactions with regulatory agencies and customers in inspections and audits. * Experience with all phases of the product development lifecycle, including concept, design, implementation, verification, and validation activities necessary for product commercialization * Experience in cGMP and other regulatory compliance requirements * Hands-on experience with FDA Federal and State Audits For_immediate_consideration_please_send_your_CV/resume_to: Show moreShow less