• Prepares overall project quality plans including milestones, validation processes and documentation
• Conducts special analyses and projects as required.
• Resolves and/or facilitates resolution of problems including identifying causes to prevent reoccurrence.
• Responsible for problem resolution, communication and policy implementation.
• Support all Company initiatives as identified by management and in support of Quality Management
Systems (QMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements,
Company policies, operating procedures, processes, and task assignments.
• Maintains positive and cooperative communications and collaboration with all levels of employees,
customers, contractors, and vendors.
• Performs other related duties and responsibilities, on occasion, as assigned.
• A Bachelor's degree in an applicable engineering discipline with ten (10) plus years of progressively
more responsible work experience in quality assurance and design related to medical devices, preferably
in electro-mechanical and implantable medical devices (class III and IV).
• Broad cross-disciplinary and in-depth knowledge and experience with industry accepted quality
assurance design methodologies and project management tools.
• Direct cybersecurity and product development experience.
• Five years or more in quality or R&D engineering management.
• Desired: An advanced credential in a relevant discipline/concentration. Professional certification or
designation, such as CQE, CSQE, CRE and/or CMQ/OE.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Strong leadership skills, including the ability to set goals and provide positive and constructive
feedback respectfully to build positive relationships and improve business results.
• Ability to work effectively within a team in a fast-paced changing environment.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in
• Multi-tasks, prioritizes and meets deadlines in timely manner.
• Strong organizational, planning, and follow-up skills and ability to hold others accountable.
• Ability to maintain regular and predictable attendance.
Security, Cybersecurity, Medical Device, Quality Engineering, FDA, ISO, Engineering