Position Overview
Innova Vascular has developed two venous thrombectomy products and has additional products in development. With Abbott as an early investor, Innova Vascular has raised $15M to scale manufacturing capabilities and U.S. commercial efforts. Innova Vascular is hiring a Head of Quality.
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Media: Innova Vascular announces successful early commercial use of Laguna thrombectomy system in patients
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Press: Innova Vascular has positive early commercial data for thrombectomy system
We have partnered with Sanjay Shrivastava, CEO, to hire our Head of Quality. This is an opportunity to lead a robust quality system, own manufacturing and supplier quality activities, and support our cross-functional R&D team across new product development and commercial expansion. Innova Vascular has its own 4,200 square foot facility, with further expansion planned within the next two years. This position will report directly to the CEO, who previously led M&A for Johnson & Johnson and successfully founded and exited Black Swan Vascular to Sirtex.
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Position Details
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Job Responsibilities
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Drive excellence in design assurance including supporting product development teams with the quality function’s activities and ensuring compliance to applicable standards and regulations.
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Support manufacturing function with the quality assurance needs to ensure the product manufactured is compliant per the procedures and specifications.
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Maintain company’s quality management system (QMS) including updating it as needed to ensure continued compliance with applicable regulations, laws, and standards.
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Provide critical quality engineering direction to projects concerning generally accepted quality engineering tools/principles, such as product and component qualification, process validation, measurement systems analysis, test method validation, root cause analysis, risk analysis, risk mitigation, sampling, and control plans.
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Act as a liaison with external parties such as suppliers on quality matters.
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Manage supplier quality including auditing them as required.
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Host external audits such as the FDA inspections and notified body audits.
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As a management representative, prepare and conduct management Reviews with Innova’s leadership team.
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Review and maintain post-market surveillance data and files.
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Manage non-conformance reports (NCR) and corrective and preventive actions (CAPA).
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Maintain risk management file, the design history files and the device master records.
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Maintain training records for company employees and ensure that they are up to date.
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Maintain Innova’s documentation control system including organizing and updating it as needed to meet company objectives.
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Manage company’s safety and occupational hazard procedures and ensure compliance with applicable laws and regulations
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Assume additional responsibilities and perform other duties as assigned.
Qualifications and Experience
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B.S. Degree in engineering required; M.S. preferred
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At least 8 years of experience in quality function including 5 years as a manager in the medical device industry
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At least 3 years in the interventional medical device industry
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At least 3 years in manufacturing, quality function
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At least 2 years in R&D, quality function
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Experience working in manufacturing and/or R&D functions is a plus and can be applicable in lieu of the related quality experience
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Strong knowledge of design and development in accordance with ISO 13485/FDA 21 CFR 820 including design input/output, design verification/validation, process validation, risk management and test method validation as it relates to the QMS.
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Knowledge of applying statistical analysis for process control, and design of experiments
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Knowledge of good manufacturing practices
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Ability to successfully balance and prioritize multiple ongoing projects/tasks in a medical device fast-paced, deadline driven environment
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Experience with NCR and CAPA
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Experience with notified body audits
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Experience with certifications such as ISO 13485 and EU medical device regulation
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Demonstrated ability to work as a team with other functions such as R&D, manufacturing and regulatory
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Good written and verbal communication skills
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Company Overview
Innova Vascular is engaged in developing innovative medical devices for treating vascular disease using minimally invasive approach. Innova Vascular is located in beautiful southern California, which is a hub for medical device development for vascular disease. The area benefits from the availability of top engineering talent pool and leading academic institutions such as Cal Tech, UCLA, UCSD, UC Irvine, USC and others within a short drive.
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CEO
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