Quality Engineer
6 days ago
We are looking for Quality Engineer for our client in Irvine, CA
Job Title: Quality Engineer
Job Location: Irvine, CA
Job Type: Contract
Job Description:
Pay Range: $38.73hr - $43.73hr
Responsibilities:
- Support areas of Quality Assurance, Design Controls, Risk Management, Manufacturing Controls, and Statistical Techniques for New Product Development (NPD) programs.
- Investigate complex manufacturing product quality and compliance issues reported from the field, analyze results, determine root cause/probable cause, and initiate and review reports.
- Coordinate and execute change control activities to support rapid innovation.
- Support design and development activities (i.e., engineering study, feasibility testing, drawing review, etc.).
- Participate in escalation tasks and activities, including Project Risk Assessments (PRA).
- Supports or leads test method development/validation activities for Design Verification testing and manufacturing inspections for NPD programs.
- Collaborate with R&D and Manufacturing organizations to facilitate the successful execution of the NPD process and launching of robust products.
- Develop complex experiments and tests (including writing and executing protocols) to create, improve, and validate products and manufacturing processes by analyzing results, making recommendations, and developing reports.
- Develop, update, and maintain technical content of risk management files.
- Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes.
- Assign and oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work.
- Other incidental duties assigned by Leadership.
- Ability to travel up to 10% domestically and internationally.
Required Qualifications:
- Bachelor’s degree in Engineering or Scientific field with a minimum of (2) years of experience in either NPD, Quality Engineering, R&D, and/or Manufacturing.
- Master’s degree in Engineering or Scientific field with internship, senior projects, or thesis experience required.
- Engineering experience within a highly regulated industry.
Preferred Qualifications:
- Experience in medical devices (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment preferred.
- Knowledge and experience within Design Assurance, including Design Controls, Design Verification & Validation, Test Method Development, and Process Validation.
- Experience with root cause analysis or investigations for Complaints, NCRs, and/or CAPAs.
- New Product Development experience from initial concept to commercialization (Class III preferred).
- Experience with Risk Management and Design Control.
- Proven expertise in the usage of MS Office Suite including MS Project.
- Basic understanding of statistical techniques.
- Strong problem-solving, organizational, analytical, and critical thinking skills.
Education/Experience:
- Bachelor's degree in engineering required.
- 2-4 years’ experience required.
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