Lab Technician
Irvine, CA
Schedule:
Standard Office Hours
Duration:
12-Month Contract
Pay:$20-25/hr
Our client is a leading global medical technology company specializing in patient-focused innovations for structural heart disease and critical care monitoring. The main function of a lab technician is to perform return complaint product evaluation and associated activities.
Job Responsibilities
In this role, you will manage and support a variety of projects within the Quality Engineering department. Key responsibilities include:
- Leading multiple quality-related projects, including:
- Investigating customer complaints for medical devices
- Analyzing manufacturing processes and data
- Implementing corrective and preventive actions
- Driving continuous improvement in product quality and compliance
- Ensuring compliance with applicable quality standards and regulatory requirements for medical devices
- Collaborating with cross-functional teams and stakeholders to ensure project success
- Coordinating and conducting independent investigational testing/analysis, including data collection and analysis under supervision
- Acquiring images using Digital Microscope and X-ray Systems
- Preparing and documenting laboratory data/summaries in accordance with in-house guidelines
- Observing and drawing conclusions regarding testing performed
- Maintaining accurate and complete records, methods, measurements, and observations related to assigned projects/evaluations
- Supporting day-to-day laboratory functions
- Participating in special projects related to evaluation of existing and developmental products and processes
Essential Duties and Job Functions
- Perform thorough investigations of customer complaints, providing detailed analysis of processes and data
- Execute complaint investigations using a multifunctional approach, addressing issues systematically
- Oversee all phases of complaints requiring investigation, ensuring timely completion
- Collaborate closely with investigation owners to resolve issues and address overdue cases
- Verify that complaint investigations are adequate and comply with applicable procedures
- Apply quality engineering principles to ensure regulatory compliance and optimize product development, manufacturing, and distribution processes
- Investigate moderately complex manufacturing quality and compliance issues for all production processes
- Optimize manufacturing processes using engineering methods like Six Sigma and Lean
- Develop and maintain technical content of risk management files
- Create training and documentation materials for production processes
- Assign and coordinate tasks for technicians, providing guidance and feedback
Knowledge & Skills
- Strong documentation, communication, and interpersonal skills
- Attention to detail and problem-solving skills
- Basic understanding of statistical techniques
- Basic ability to work independently and manage one's time
- Basic ability to analyze data and accurately document and record results
- Experience working with laboratory/industrial equipment
- Solid understanding of engineering principles, theories, and concepts
- Strong organizational, analytical, and critical thinking skills
- Thorough understanding of processes and equipment used in assigned work
- Knowledge of and adherence to quality systems
- Meticulous attention to detail
- Ability to interact professionally with all organizational levels
- Capability to manage competing priorities in a fast-paced environment
- Proficiency in teamwork, including vendor and stakeholder management
- Ability to build productive internal/external working relationships
- Adherence to all company rules and requirements (e.g., safety protocols)
- Proficiency with computer applications and software related to engineering, such as CAD
Education & Experience
- Bachelor's degree in Engineering or Scientific field
- 0-2 years of relevant experience required
- Experience in medical device industry preferred
- Familiarity with quality systems and regulatory requirements for medical devices is highly desirable
- Certification in quality engineering or related field is a plus
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