A global Medical Device company in Irvine, CA is looking to identify and hire a Quality Engineer II
for the New Product Quality Engineering team, who will work with a team to develop and validate in-process inspections for the transcatheter heart valve delivery system manufacturing line. The individual will be responsible for assessing current inspections against internal standards, external regulations, and identify areas of improvement. This position will work closely with R&D and manufacturing engineers, as well as operations partners, to develop and validate robust in-process inspections. The Engineer II will work with regulatory affairs and other core team members to implement changes in a highly regulated change control environment. This position is responsible for helping to develop an implementation plan and executing tasks in a timely manner.Essential Job Functions:
Skills & Qualifications:
- Identify areas of unclear or sub-optimal inspections.
- Be a driver for implementing changes to manufacturing processes.
- Design & qualify engineering tooling / fixtures
- Work with production operators and inspectors on the manufacturing floor to help improve their day to day work
- Author and execute validation protocols for new test methods.
- Create and maintain engineering documentation
- Provides updates, strategy recommendations, and plans to management, as needed.
- Performs analyses looking for areas of simplification and improvement.
- Characterizes new manufacturing processes and implement improvements based upon learnings.
- Bachelor's degree in Engineering required
- Document Change Control Experience required
- Technical Protocol writing
- Minitab/Gage R&R
- Be comfortable with working in a clean-room environment
- Manage test method validations
- Experience with statistical analyses tools
- Operations or manufacturing experience a plus
- Hands-on problem solving and enjoy working in a dynamic and fast paced environment.
- Strong communication and interpersonal skills.
- Strong in developing working relationships with cross functional teams.
- Ability to handle multiple tasks with attention to details.
- Project ownership and accountability for project results.
We are an equal opportunity employer and make hiring decisions based on merit. Recruitment, hiring, training, and job assignments are made without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, or any other protected classification. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
Total Quality Management
Provide Technical Guidance