Quality Engineer II at TalentBurst

Position: Quality Engineer II, Req#: 9479-1
Location: Irvine, CA (100% Onsite)
Duration: 6+ Months Contract

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.

What are your top required technical skills? Must haves?

• DHR/LHR reviews (need to understand how to manage this once we convert to Irvine clinical distribution)
• Review technical manufacturing / QA documentation. Work orders, NCRs, etc. Some will be in Mandarin, so we will need to search out with them to figure out exactly what to look for in their review. Someone who is fluent and can read Mandarin would be ideal, but not necessary.
• Complaint coordination (logistics, tracking list, follow-ups, communications, kicking off changes/CAPA)
• Manage spreadsheets with complaints list, assign tasks, follow up, send communications (Complaint handler experience ideal, but not mandatory)
• Coordinate and review any CAPA/NCR
• Keep list, status, and update accordingly.
• Coordinate, and conduct Management Review
• Schedule meetings, assemble slides
• Document specialist
• Coordinate approvals through Adobe Doc-U-Sign, send communications, coordinate reviewers and implement their -Microsoft suite software redlines.

Education and Experience:

• Bachelor's degree in engineering required.
• 2-4 years of experience required.
• Bachelor’s degree in the Engineering 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

Additional Skills:

• 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

Job 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