Sr. Quality Engineer
We are looking for Sr. Quality Engineer for our client in Irvine, CA
Job Title: Sr. Quality Engineer
Job Location: Irvine, CA
Job Type: Contract ? 12 Months / Contract to Hire / Direct Hire
?US citizens and those authorized to work in the US are encouraged to apply. We are unable to sponsor H1b candidates at this time.?
Senior Quality Engineer:
- This is a great opportunity for a Senior Quality Engineer to join the Transcatheter Heart Valve (THV) new product development (NPD) team. The Sr. Quality Engineer (QE) will support THV Self-Expanding R&D projects, focusing on design control, design verification/validation, failure analysis, FMEA, specification development, statistical reliability, acceptance sampling and inspection/test methodologies. The Sr. QE will work in a fast paced and dynamic environment where taking initiative and collaborating cross-functionally are critical for success.
- Collaborates with the R&D organization to help facilitate the successful execution of the NPD process and launching of robust products. Provides expertise in root cause analysis and corrective action during the design process. Critical review and approval of design changes
- Partner with Manufacturing Engineers to develop critical manufacturing processes and provide technical quality support for the pilot production of clinical devices. Support IQ/OQ/PQ activities for commercialization.
- Managing purchased component quality issues and working directly with Suppliers or Supplier Development teams.
- Component drawing and router updates
- PQP & SQR ? supplier development support
- Provide technical quality support for design qualifications, design transfer, and activities for Regulatory submissions.
- Root cause analysis investigation for component and device non-conformance or failure.
- Develop and implement risk management documentation including risk management plans and design, application, and process FMEAs.
- Production readiness and commercial ramp up phase
- Process validation ? cut in 100% verification of tests from PV
- Test Method Validation
- Cost reduction activities
- Leads test method development/validation activities for NPD programs. Creates test plan for design verification and product verification testing.
- Next generation product experience i.e. design control, design verification/validation, failure analysis, FMEA, specification development, statistical reliability, acceptance sampling, and inspection/test methodologies
- Work hand in hand with R&D
- Feasibility testing in lab
- Stats analysis ?2 sample t, equivalency test, etc.
- Prototype ordering, design specification development
- Ensures NPD team compliance to the company products, policies, and procedures.
- Responsible for ensuring compliance with all Federal, State, local and company regulations, policies and procedures.
- Performs other duties as assigned
- A Bachelor of Science degree in Mechanical, Biomedical, or equivalent engineeringdegree is required.
- Minimum of 4years?experience in Quality or Manufacturing is required.
- Experience in design verification, risk management, and design control in the medical device industry or other regulated industries is required.
- Must be able to work effectively and collaborate within cross functional teams.
- Must be able to effectively articulate (verbally and in writing) results and conclusions to technical and non-technical personnel.
- Must have excellent documentation skills.
- Must take initiative and have the ability to work hands-on with product and equipment.
- Must possess the ability to handle multiple tasks with high attention to detail.
- Quality engineeringexperience in new product development is preferred.