Position Title: Quality Test Engineer Work Location: Irvine, CA 92618 Assignment Duration: 5 Months Work Arrangement: Onsite
Position Summary: The Quality Test Engineer performs investigations relating to root cause of customer complaints, proposes and implements corrective and preventative actions as required.
Background & Context: Under supervision, general direction, and in accordance with all applicable federal, state and local laws/regulations and the organization's procedures and guidelines, this position is focused on quality investigations for medical device capital equipment.
Key Responsibilities:
Responsible for investigating customer complaints regarding product design, product manufacture, and product testing
Responsible for communicating quality and business-related issues or opportunities to the next management level.
Participates in projects that improve the complaint process and reduces overall customer issues.
Actively participate and engage in CAPA trending meetings.
Analyzes data and applies knowledge of engineering principles and practices to implement continuous improvement projects.
Provide support during External and Internal Audits of the Customer Quality process
Performs other duties assigned as needed.
Responsible for complying with all Federal, State, local and company regulations, policies and procedures including Health, Safety and Environmental compliance.
Qualification & Experience:
Bachelor’s degree in engineering.
Minimum of two (2) years of experience in an engineering related field
Able 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.
Has an understanding of statistics and how to utilize them in data analysis
Must possess a clear understanding of theoretical and practical fundamentals and experimental engineering techniques. Good written and oral communication skills. Computer literate.
Demonstrated root cause and problem-solving skills.
Demonstrated verbal and written communication skills, and ability to effectively communicate 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 are preferred
Understanding of Human Factors and Health Hazard Risks are preferred
Knowledge of design control, risk management, production and process controls and applicable laws (i.e., ISO 13485, FDA Quality System Regulation, ISO 14971) is preferred
Proficiency with quality-related applications such as those for Minitab, QI Macros, etc would be a plus.
Experience with CAPA, NCR and Audit software systems is desired.
Note:
More prioritization of document NC, complaints, work on electrical testing, multiple device testing - ENT product
ENT experience would be amazing, but NC/complaints experience preferred
Expert excel user
Applicant Notices & Disclaimers
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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position's pay range is $48.00/hr - $54.00/hr.
