Quality Engineer

2 weeks ago

Irvine, United States Cynet Systems Full time
Pay range: $30 to $36.00

Job Description:

Qualifications:
  • Planned, organize, and prioritize complaint investigation activities based on complaint closure and reportability timelines.
  • Perform analysis in No Product Return Evaluations by utilizing multiple data inputs including technical review of device history records (DHR review), in support of complaint investigations
  • Perform testing, assess results, and document routine complaint product device evaluations in support of complaint investigations including dimensional and functional analysis.
  • Collaborate with other engineers on non-routine testing in support of failure investigation and root cause analysis.
  • Generate weekly complaint reports to provide data for weekly production meetings.
  • Organize and track complaint product returns and investigational follow-up inquiries related to product investigations in partnership with complaint handlers.
  • Perform queries on historical complaint data to support complaint investigations.
  • Collaborate with other Engineers in preliminary complaint product evaluations to determine standard or non-routine device failures.
  • The document, communicate, and escalate results, as applicable.
  • Ability to interact professionally with all organizational levels
  • Ability to manage competing priorities in a fast-paced environment
  • Must be able to work in a team environment, including the ability to manage vendors and project stakeholders
  • Ability to build productive internal/external working relationships
  • Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of the environment and prevention of pollution under their span of influence/control.
Skills:
  • Good documentation, communication, and interpersonal relationship skills including negotiating and relationship management skills.
  • Solid problem-solving, organizational, analytical, and critical thinking skills.
  • Knowledge of and adherence to Quality systems.
  • Strict attention to detail.
  • Basic understanding of statistical techniques.
  • Previous experience working with lab/industrial equipment is required.
  • Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering.
  • Solid understanding of processes and equipment used in assigned work.
  • Nice to have: EQMS Reliance Exp plus, Power BI, Excel.
Education:
  • Bachelors degree in scientific, Bio-Medical, or engineering field, and 1-year previous quality compliance and medical device (cardiovascular, endovascular, or other surgical products), healthcare, or a related environment required.

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