Manager, Quality Systems
Cardiocom - Chanhassen, MN

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Cardiocom is a fast growing medical device and telehealth solutions company with manufacturing, engineering and nurse call center services located in Chanhassen, Minnesota. Cardiocom is positioned to revolutionize this fast-growing industry. Take the next step in your career! Join a progressive, dynamic and vibrant company thats on the leading edge of telehealth. Get to know more about Cardiocom - visit The Manager, Quality Systems is responsible for US and international quality systems compliance and regulatory review. Reporting to the CEO, this is a core management team member working with manufacturing and development teams. This role also manages quality assurance/engineering and document control functions. POSITION RESPONSIBILITIES: Act as Company Management Representative for the companys quality systems Ensure compliance with ISO 13485, FDA QSR, MDD, IVDD, CMDR, and other worldwide medical device standards/regulations Act as core team member on manufacturing and development teams Perform quality management system duties such as review of internal and external audits, CAPA's, complaints, non-conforming material, metrics, supplier quality reviews, risk management, etc. Supervise Document Control and Quality Assurance/Engineering Provide Quality Systems training for all personnel Complete gap analysis of current products intended for new markets Complete annual FDA Establishment Registration and Device Listings updates as needed Prepare appropriate documentation to maintain CE Mark certification with Notified Body, including annual renewal Review FDA guidance documents and international standards to determine applicability to products on the market and under development Gain regulatory approvals by preparing and submitting US and international regulatory applications including FDA 510(k)s, EU Technical Files, and Canadian licenses Document regulatory assessment of product and manufacturing changes, including 510(k) letter-to-file Create and implement regulatory strategies for new and modified medical devices
Education: A minimum of four-year engineering, science degree or equivalent. Experience: 5+ years' experience in medical device quality assurance and /or regulatory. Experience with quality systems including supplier metrics, internal and external audits, equipment calibration/preventive maintenance, quality assurance, CAPA's, complaints, risk management, nonconforming material, management reviews. etc. Thorough understanding of FDA and international medical device regulations required including software regulations. Working knowledge of manufacturing, product development, design control and risk management. Experience writing global regulatory submissions a plus but not required.Other: Ability to interface with all groups and levels to solve problems and create solutions. High level of verbal and written communication skills and technical writing. Highly motivated and good attention to detail. Good computer skills. Ability to manage multiple projects. Ability to work independently with minimal supervision.SALARY, BENEFITS and OTHER Competitive salary based on experience. Medical, dental, 401K, flex spend, life insurance and PTO. CARDIOCOM is an EEO/AA employer. For more detailed company information, visit the Cardiocom website at

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