THV Quality Engineer

2 months ago

Irvine, United States Entegee Full time
Job DescriptionJob Description

Summary: Seeking a THV Quality Engineer to investigate product quality issues, perform device testing, and manage complaint investigations in the medical device industry.

Requirements:

  • Bachelor's degree in engineering with 0 - 2 years of related work experience.

  • Experience with medical device complaint investigations, including CAPAs, NCRs, and Root-Cause Analysis.

  • Proficiency with the Microsoft Office suite.

  • Experience performing functional, physical, and visual testing of medical equipment in a laboratory setting.

  • Basic understanding of statistical techniques.

  • Solid knowledge of engineering principles, theories, and concepts.

  • Familiarity with Quality systems and adherence to their regulations.

Preferred Skills:

  • Experience in the medical device field (cardiovascular, endovascular or critical care/surgical products).

  • Good documentation skills along with strong communication and interpersonal relationship abilities.

  • Previous experience working with lab/industrial equipment.

Responsibilities:

  • Investigate complex product quality and compliance issues from the field; analyze results to determine root causes/probable causes.

  • Perform hands-on device investigation using various test equipment to determine root cause.

  • Assess events against risk documentation for clinical/compliance risks; escalate as necessary.

  • Participate in escalation tasks such as Project Risk Assessments (PRA) and Corrective/Preventive Actions (CAPAs), SCARs based on investigation findings.

  • Report key complaint metrics by device category; collaborate with manufacturing teams to resolve production/device related issues.

 

 Pay: 35-40

Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client.

 

 



Pay Details: $30.00 to $40.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.entegee.com/candidate-privacy-information-statement/

The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.Company DescriptionSpecializes in custom automation projects, they are a major player in the world of controls and robotic solutions around the world. My client will expand anyone resume and build them to be a top performing controls engineer.Company DescriptionSpecializes in custom automation projects, they are a major player in the world of controls and robotic solutions around the world. My client will expand anyone resume and build them to be a top performing controls engineer.

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