Engineering - Engr II, R&D CA

6 days ago


irvine, United States TalentBurst Full time
Job Title: Quality Engineer II
Duration: 6 Months Contract
Location: Irvine, CA

Job Description:
This Quality Engineer II will apply knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and systems/procedures to optimize product design, internal and external device manufacturing, and device distribution. Furthermore, this Quality Engineer will coordinate and perform complaint investigations as well as DMR/DHR changes in support of clinical inventory.
How you will make an impact:
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; OR a 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 device (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 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.
#TB_PH

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