As a key member of the Quality Engineering team, the QE, ME acts as a quality representative on cross-functional project teams to:
- assess risks/hazards associated with product designs, processes and applications
- create quality – related documentation for project design history files
- develop and execute product tests and validations
- analyze resulting data, and document results, and
- develop and implement processes and procedures.
• Represent Quality Engineering on cross – functional project teams
• Create quality – related documentation for project design history files (quality plan, essential requirements checklist, etc.)
• Lead teams in identification of risk/hazards associated with product designs, processes and applications and assist with FMECA generation.
• Develop test plans, write protocols, analyze data, and document results in technical reports (product and system validations, sterilization validations, package integrity testing and biocompatibility testing)
• Interface with design engineering and develop first article inspection plans
• Ensure compliance with product and industry requirements and champion Quality policies and principles through the company.
Experience and Training:
• Bachelors degree in Biomedical Engineering or related
• Minimum one year work – related experience in Quality Engineering or a combination of Quality Engineering and Design/Product Development Engineering in the medical device industry and possess a field related Bachelor’s degree.
• Ability to analyze problems, work independently as well as in a team environment, and organize and execute multiple work tasks simultaneously
• Ability to read and interpret engineering drawings, product specifications, procedures and standards
• Experience with active implantable medical devices and class III devices a plus
• Experience/familiarity with the domestic and foreign standards related to medical devices preferred; knowledge of these standards related to active implantable medical devices preferred
• Experience executing sterilization validations desired
• Knowledge and experience with biocompatibility is preferred
• Must be proficient in MS Office (Microsoft Word, Excel, PowerPoint, Outlook)
• Excellent written and oral communication skills
• Good conflict management skills
• Ability to learn quickly and multi task
• Self motivated and able to work independently as well as in a team environment.