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 that’s on the leading edge of telehealth.
Get to know more about Cardiocom - visit http://www.youtube.com/watch?v=O-dD11zePdo&feature=youtu.be .
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.
- Act as Company Management Representative for the company’s 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
American Society For Quality
- 2 years ago - save job