Specific responsibilities:

• Collaborate with hardware, systems and software engineering and other product development teams in establishing standard operating procedures for the definition of design history file (DHF) and device master record (DMR) deliverables.
• Guide medical device development teams in their execution strategy for Design and Risk SOPs, review, approve, and audit DHF elements (e.g., plans, requirements, specifications, test protocols, test results, design traceability, risk management documents, design reviews, reports).
• Train and coach cross-functional peers on maintaining compliance to internal and external medical device quality system requirements and regulations.
• Perform internal audits and possible contract manufacturer audits to verify compliance with QMS requirements for design, development, and manufacturing of medical devices.
• Establish growth plans and hire excellent talent to the organization that intelligently scales with the business needs.

Qualifications:

• Experience with establishing Hardware quality management for medical devices is a must.
• Bachelor’s Degree in Biomedical, Mechanical or Electrical Engineering or other Technical Science.
• 10+ years of work experience in a highly regulated industry (e.g., Medical Devices, Bioengineering, LifeSciences, Quality and/or Development).
• Experience in the application of ISO 13485, ISO 14971, 21 CFR 820 and other US regulations, IEC 62304, IEC 60601-1, MDD & EU MDR.
• Experience authoring technical reports, business correspondence and standard operating procedures.
• Proven communication skills. Experience presenting clearly and persuasively to technical and non-technical audience.
• Proven leadership qualities in hiring and retaining top talent, championing new initiatives in a large organization, and representing the organization to outside regulatory agencies.
• Experience electronic Quality Management System tools for best in class documentation and record keeping practices.
• Prior experience establishing a new QMS.
• Experience with Hardware devices as well as Software as a Medical Device product development.