Quality Test Engineer

Job Title: Quality Test Engineer

Job Location: Irvine, CA

Job Type: Contract

Pay Range: $51.17hr - $56.17hr

Job Overview:

The Quality Test Engineer performs investigations relating to the root cause of customer complaints and proposes and implements corrective and preventative actions as required.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Under supervision, general direction, and in accordance with all applicable laws, regulations, and corporate procedures and guidelines, this position includes the following responsibilities:

• Investigating customer complaints regarding product design, product manufacture, and product testing.
• Communicating quality and business-related issues or opportunities to the next management level.
• Participating in projects that improve the complaint process and reduce overall customer issues.
• Actively participating and engaging in CAPA trending meetings.
• Analyzing data and applying knowledge of engineering principles and practices to implement continuous improvement projects.
• Providing support during external and internal audits of the customer quality process.
• Performing other duties assigned as needed.
• Complying with all federal, state, local, and company regulations, policies, and procedures, including health, safety, and environmental compliance.

DESIRED MINIMUM QUALIFICATIONS:

• Bachelor s degree in engineering.
• Minimum of 2+ years of experience in an engineering-related field.
• Ability to read and understand electrical and mechanical schematics.
• Strong integration skills to identify manufacturing and supplier-related issues of medical device capital equipment.
• Ability to apply technical, regulatory, quality systems, and business knowledge to identify, investigate, and resolve customer complaints.
• Ability to effectively prioritize and manage multiple activities and responsibilities.
• Understanding of statistics and how to utilize them in data analysis.
• Clear understanding of theoretical and practical fundamentals and experimental engineering techniques.
• Strong verbal and written communication skills and computer literacy.
• Demonstrated root cause and problem-solving skills.
• Demonstrated verbal and written communication skills, with the ability to communicate effectively with internal and external personnel.
• Ability to apply Six Sigma and Process Excellence tools and methodologies preferred.
• Understanding of Failure Modes and Effects Analysis and Fault Tree Analysis preferred.
• Understanding of Human Factors and Health Hazard Risks preferred.
• Knowledge of design control, risk management, production and process controls, and applicable standards (e.g., ISO 13485, FDA Quality System Regulation, ISO 14971) preferred.
• Proficiency with quality-related applications such as Minitab or QI Macros is a plus.
• Experience with CAPA, NCR, and audit software systems desired.

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• Medical, Dental, and Vision Insurance
• 401(k) Retirement Plan
• Health Savings Account (HSA)
• Disability Insurance (Short-Term and Long-Term)
• Life and AD&D Insurance
• Paid Sick Leave (where required by applicable state or local law)
• Supplemental Insurance Plans
• Identity Theft Protection
• Pet Insurance
• Employee Wellness Programs
• Employee Assistance Program (EAP)
• Career Growth and Professional Development Opportunities