Quality Assurance Engineer Job

QUALITY ASSURANCE ENGINEER needed for a THREE (3) MONTH CONTRACT, opportunity with Yoh's Medical Device client located in Hayward, CA.

WHAT YOU'LL BE DOING:

- In this role you will actively participate in new product introduction activities, ensuring conformance to FDA and ISO 13485 standards
- You will facilitate teams in identifying, documenting, assessing, correcting and preventing quality issues using risk analysis and root cause analysis tools
- You will be responsible for quality planning and establishing and maintaining metrics to improve quality system processes, process capability, reliability and quality of products
- Support manufacturing and field sustaining leading to improved compliance with corporate policies, 21CFR820, ISO 13485, the Medical Device Directive, and other applicable regulatory agencies, while striving for continuous improvement

WHAT YOU NEED TO BRING TO THE TABLE:

- Bachelor degree in a technical field desired, preferably Mechanical Engineering and ASQ certification desired
- Five to seven (5 - 7) years of experience in quality assurance field in a medical device manufacturing environment.
- Working knowledge of the FDA medical device Quality Systems Regulations and ISO 13485
- Experience with failure investigations, risk management and failure report writing
- In-depth knowledge of SPC, and process capability studies
- Must have capability to review, analyze, summarize and interpret quality systems data, draw conclusions, make appropriate decisions and recommendations, write reports and give oral presentations
- In-depth knowledge of SPC, and process capability studies.
- Working knowledge of the FDA medical device Quality Systems Regulations and ISO 13485.
- Experience with failure investigations, risk management and failure report writing.

GET HIRED, APPLY NOW!

RECRUITER: Omari Sealey

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