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|Job Category :
||Cerritos, CA 90703
|Job Description :
If you are a QA Engineer with experience, please read on!
We are a medical device start up changing lives one person at a time. In this role, we are looking for a motivated team member who is keen to contribute to this active and dynamic project. The ideal candidate require the ability to work with minimal supervision and is interested in the opportunity to further grow towards a QM. As the Quality Assurance Engineer, you are responsible for reviewing and analyzing data, performing root-cause investigations, establish action plans and implement actions. As well, ensuring the quality system is compliant with regulations including the FDA Quality System Requirements (QSR), ISO 13485 and 21 CFR 820. We have created a total artificial heart and we want you be apart of something amazing!
What You Will Be DoingWork with internal engineering staff from mechanical and electrical engineering backgrounds to the support manufacturing planningAct as a liaison between the company and external vendors/suppliers to ensure QA activities are sufficiently undertaken to support product developmentReview, analyze, summarize, and interpret data; draw conclusions, make recommendations/write reports; and give oral presentationsDetailed knowledge in manufacturing processes and engineering principlesExcellent written and verbal communication skills to serve as liaisons between companies and suppliers and prepare quality assurance reportsReview and analyze data, performing root-cause investigations to establish corrective action plans and implement corrective actions, developing and performing test methods for product inspections, testing and investigations, writing and updating procedures as required to ensure the quality system is compliant with regulationsConducts assessments/ tests on batches of products to identify recurring errors or quality issuesCreate, edit, and maintain documentation related to design controls and quality system guidelinesMaintain detailed reports related to supplier quality report on supplier quality status and drive changes in vendor/supplier processes
What You Need for this PositionBachelors Degree in Engineering or equivalent3 years experience as a Quality Engineer
Medical Device Experience preferredMust have a hands-on approachMedical Device Quality System knowledge (21 CFR Part 820 (QSR) & ISO 13485)CAPA team, leading continuous improvement
Strong statistical analysis skills and needs to be able to rigorously assess and analyze supplier or vendor data along with internal metrics
What’s In It for You
– $75K – $90K DOE
Join a Series B Start up
Vacation/PTOMedical/ Dental/ Vision401k Match
So, if you are a QA Engineer with experience, please apply today!Applicants must be authorized to work in the U.S.
CyberCoders, Inc is proud to be an Equal Opportunity Employer
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law.
Your Right to Work – In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.
CyberCoders will consider for Employment in the City of Los Angeles qualified Applicants with Criminal Histories in a manner consistent with the requirements of the Los Angeles Fair Chance Initiative for Hiring (Ban the Box) Ordinance.
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