Company Summary:

410 Medical, based in Durham, NC, is focused on innovative technology to improve resuscitation of critically ill patients. 410’s lead product, LifeFlow, is designed to enable clinicians to more effectively and efficiently deliver fluids to patients with shock and sepsis in urgent need of rapid fluid resuscitation. LifeFlow was cleared by the FDA in 2016 and is currently being marketed in the United States. Position Summary: The Director of Quality & Regulatory will drive all aspects of policy, training and company guidance on Design Control and Risk Management activities. This position will lead the R&D team from concept through market introduction, as well as manage existing product in the field. The position will be integral in the delivery of Quality Design deliverables and verifying the Quality Management System requirements have been met while meeting time-to-market objectives. Additionally this role covers successful completion of ongoing government audits, including ISO and FDA. This position is key to ensure documentation control maintenance and compliance and complaint resolution. In tandem with the Executive Team, this candidate will lead the continuous improvement of the Design Control and Risk Management systems to more effectively deliver business and quality objectives.

The specific roles and responsibilities includes those listed below.

Duties and Responsibilities:

  • Maintain Quality System compliance with ISO13485:2016 and FDA regulations
  • Responsible for strategic oversight and leadership of In-Coming Inspection, In-Process Inspection, Finished Goods Inspection, Final Product Release, Quality Engineering, Customer Complaint Investigation, Supplier Quality and Calibration/Metrology
  • Knowledge of FDA regulatory requirements (QSRs – 21 CFR Part 820)
  • Knowledge of International regulatory requirements (ISO 13485:2016, MHRA GMPs, etc.)
  • Manage all complaint process and corrective actions as required
  • Responsible for Production and Process Controls from a Quality perspective
  • Serves as a technical resource for all QA activities
  • Identifies data requirements, often beyond the standard, and collects all relevant data needed to analyze a complex problem, situation or issue
  • Advises others on a variety of topics within own functional area
  • Tracks internal trends and suggests process improvements based on observations
  • Applies hypotheses and an understanding of cause and effect when analyzing a complex process, situation or issue or discerning data patterns
  • Serves as the QA subject matter expert (SME) for internal/external regulatory compliance audits
  • Drives team to achieve established goals in proactive and pragmatic manner; adjusts plan of action accordingly to maneuver obstacles and achieve success
  • Manages budget for own area, allocates resources and delegates accordingly, applying knowledge of profit drivers within own area / department
  • Maintain complete, accurate and up-to-date documentation on Certificates of Compliances, product release documentation, sterilization process review and approval, corrective actions system and complaint processing
  • Presents bi-annual Quality Management Reviews to senior management

Skills/ Qualifications:

  • Bachelors or Masters Degree in Science/Engineering or related field
  • At least 12 years of industry experience working in the Medical Device industry and at least 5 years associated with New Product Development (experience in developing medical capital equipment preferable)
  • Startup or small company experience strongly preferred
  • Managerial experience strongly preferred
  • Thorough knowledge of FDA and International Regulatory requirements required
  • Excellent organizational, interpersonal, written and oral communication skills required
  • Generally works out details within broad guidelines and exercises considerable initiative and judgment
  • Additional duties as directed

Other requirements:

  • Travel 5%-20% to locations Domestic and International
  • Must be able to meet hospital credentialing requirements in order to observe products within a hospital or EMS environment
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