Quality Engineer II
Orange County Metro Area, CA
Responsible for performing and completing assigned complaint investigations that include, but are not limited to Product Failure Analysis and complaint documentation review (device history record, complaint history, products instructions, risk management, etc.), and prepare technical investigation reports.
- Facilitate with cross functional groups such as R&D, Manufacturing Engineering, and Production to ensure Quality problem resolution by means of Root Cause/Problem Solving Analysis.
- Follow up on Implementation of corrective and preventative action as required.
- Development/update of risk management documentation (i.e. Medical Device Hazard Analysis, Process Failure Modes and Effects Analysis) for products manufactured, as required.
- Support external regulatory requests with complaint risk and metric analysis as needed.
- Prepare information for Quality Management Reviews and Operational Reviews such as: trend charts, Pareto Analysis, etc., as required on complaint data.
- Bachelor's degree in Engineering or Scientific field is required plus a minimum of 2 years of applicable experience; OR Master s degree in Engineering or Scientific field plus applicable internship experience.
- Engineering degree in Mechanical, Materials, Biomedical, or similar engineering disciplines is highly preferred.
- Experience conducting complaint investigations and root cause analysis preferred
- Experience with NCRs, FMEAs, CAPAs, or Product Risk Assessments is preferred
- Prior experience in the medical device industry is preferred
- Experience with key technologies and processes related to the assembly and manufacture of Class III cardiovascular devices and delivery systems is preferred.
- Knowledge and experience using MS Office Suite.
- Good documentation, communication and interpersonal relationship skills, including relationship management skills
- Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
- Solid problem-solving, organizational, analytical and critical thinking skills
- Strict attention to detail
- Ability to manage competing priorities in a fast-paced environment
- Must be able to work in a team environment
- Ability to build constructive internal/external working relationships