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Quality Management System Lead

Max Eleven Mountain View, CA
  • Posted: over a month ago
  • Other
Title: Quality Management System Lead – Contract Position 6 months
Rate- $55/hr on w2
Company: Samsung Research America (SRA)
Location: Mountain View, CA
Lab: Samsung Health - As a cross-disciplinary Health-focused product development team consisting of research, technology, design, strategy and product functions, we define the next generation of Health service experiences for Samsung products.
Position Summary: Samsung Health is intent on offering a superior digital health experience in broad use areas, backed by world-class research, technical, supplier, and manufacturing capabilities. We need a hard-working contract Quality Management Lead to join our experienced, collaborative, entrepreneurial digital health team, backed by Samsung's global reach, to shape the future of consumer-focused digital healthcare. This role will lead refinement and management of our pre- and post-market Quality Management System (QMS) activities and our global team's adherence in pursuit of our aggressive medical device product goals. It is expected that the individual in this position will be a leading contributor in the program, helping to identify gaps and proactively/collaboratively working to fill them. A successful candidate will focus on creating and improving pre-market medical device quality processes at a high-level, working hands-on with the team to improve our design control, document management, risk management, training, and software development lifecycle processes.
Key Responsibilities:
  • Manage and innovate strategy for a growing/evolving pre-market Quality Management System within a primarily software medical device product lifecycle.
  • Modify and develop Standard Operating Procedures (SOPs) for a globally distributed team in an entrepreneurial environment.
  • Manage QMS review process, timelines, and subsequent versioning for key program artifacts/documentation following our Design Control Processes.
  • Define, track, and execute staff QMS training initiatives.
  • Lead key Supplier Quality Management initiatives.
  • Initialize an Internal Auditing program.
  • Collaboratively problem solve with other program leads.
Qualifications:
  • A minimum of a Bachelor's Degree or equivalent degree is required.
  • A minimum of 6 years of relevant experience in a regulated environment is required.
  • A minimum of 4 years of experience orchestrating pre-market medical device Quality Management System (QMS) processes for a Medical Device company is required (21 CFR 820), including full understanding of proper design control, document management, risk management, training, and software development lifecycle processes and artifacts
  • Experience with required and practical implementations of Software Development Lifecycle processes (IEC 62304) is required.
  • Working knowledge of CAPAs, Non-Conformances (Investigations) and Quality Management Review is required.
  • Experience with Product Safety Risk Management processes is required.
  • Experience with regulatory body (FDA, TUV) audits is preferred.
  • Experience creating/maintaining Post Market Surveillance plans is preferred.
  • Experience with Intland's code Beamer is preferred.

Max Eleven

Address

Mountain View, CA
USA

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