What are the responsibilities and job description for the Quality Engineer position at HealthCare Recruiters International?
Quality Engineer
San Jose, CA
The Company:
Our client is acting to develop accessible solutions of eye diagnosis for eye care professionals. They are a recognized key player on the market and have an innovative portfolio of solutions to cover most of the ophthalmologists diagnosis tools (anterior segment, retina and optical nerves imaging, angiography, cornea topography, etc.)
We are looking for a Quality Engineer for a specific product range. This position is based in our in the Silicon Valley, San Jose, California or in Lombard, Illinois.
The role:
His/her mission is to ensure our products meets the highest quality standards and all applicable regulatory requirements, to strengthen professionals trust and loyalty with our company :
- Guaranty quality success of all R&D developments (new products or products evolutions): identification of all requirements and risks, definition and execution of verification & validation strategy with R&D team and documentation.
- Ensure the transfer to manufacturing (localized in Taiwan) is meeting all quality requirements, notably in term of control and inspection procedures, by working on the process risks identification & mitigation, driving appropriate process controls and validations with our local supply base engineer.
- Lead product problem resolution in connection with complaints analysts from our various markets: problem description, root causes analysis, corrective and preventive actions, efficiency measurement, working with transversal teams (R&D, manufacturing, after sales & support)
- Lead our QMS, with daily management and employees engagement, regular system evolutions as required and ensure to maintain applicable certifications in link with notified body, certification body and government agencies (IS13485, MDSAP, MDR EU 2017/45, FDA)
Reporting to Group Quality VP, will also work closely with the RA director.
CANDIDATE REQUIREMENTS
Education & Experience :
- M.S. degree or equivalent is required
- Solid knowledge in electronic, optic and software development
- A proven experience in medical device industry and ISO13485 certified QMS
Competencies :
- Quality & Continuous improvements tool box such as FMEA, 8D, Ishikawa,…
Soft skills :
- Assertiveness and ability to drive change
- Autonomous and self-development mindset
- Results & customer oriented
- Ability to work in multi-cultural environment and to lead transversal teams
- Analytical and rigorous
- Clear and sharp communication
Regular travels to Taiwan to be considered