Head of Quality Management Systems and Design Assurance, Medical Devices Responsibilities:

• The Head of Quality Management Systems and Design Assurance will leverage operational experience to meet quality and regulatory goals, define processes within a medical device product area residing within a larger consumer electronics division.
• Establish processes and deliverables for medical device product development programs per the FDA and ISO requirements for electromechanical and SaMD products.
• Collaborate with 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.

Minimum Qualifications:

• 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, Pharma, 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.

Preferred Qualifications:

• Experience electronic Quality Management System tools for best in class documentation and record keeping practices
• Prior experience establishing a new QMS at a large, complex organization.
• RAC or CQE/CQM certification
• Experience with electromechanical devices as well as Software as a Medical Device product development.
• Significant experience and personal interactions with FDA and other regulatory agencies through audits and product submissions

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