Job Category: Technician - Laboratory, Manufacturing, Electronics, Electrical
Job Number: 12060126
Women Back to Work (WBW) candidates will also be considered for this position.
Akraya is looking for a “ Quality Engineer 1" for one of our clients. If the job description below is a fit, please apply directly or call Moiz at 408-816-2442. If this position is not quite what you’ re looking for, visit akraya.Com and submit a copy of your resume. Our recruiters will get to work finding you a job that is a better match at one of our many clients.
Primary Skills: Failure Analysis, quality engineering, medical device, Six Sigma
Duration: 6+ Months (possible extension)
Tax Term: W2 Only
This position has responsibility and authority for:
- 75% failure investigation, 25% quality advocacy and project management.
- Quality Advocacy and Project Management
- Apply corporate level quality metrics.
- Lead quality initiatives in one or more of these focus areas:
- Product Quality, Data Quality, Process Quality
- Failure Analysis
- Perform deep technical failure analysis based on the physics of failure.
- Reviews and trends product and process quality issues using data analysis and root cause investigation
- Perform risk analysis and determines quality disposition for variance requests and non-conformances
- Represents the department cross-functionally in meetings that may include senior and external personnel
- Review process and document changes through engineering change orders and deviations using client' s change control process
- Escalates to direct management all quality issues that could impact patient safety or surgical efficacy
- Ensures successful, on-time completion of department projects, communicates constraints to direct management when successful project completion is at risk
- Performs other duties as assigned by management
- Education: Bachelor degree in electrical, mechanical, biomedical or system engineering, math, or physics. Advanced degree preferred.
- Minimum 1 plus years of working experience, preferable in medical device manufacturing environment.
- Demonstrated Understanding of CFR 21 820/ ISO 13485 in a nice to have
- Understands product risks & FMEA.
- Understand mechanical complex problems with minimal oversight
- Understanding of SPC & Six Sigma methodology and tools (e.G. Uses DMAIC process and basic tools such as 5 Why' s, control charts, fishbone diagram)
- Able to create Multi-source report, trends, and interprets data with minimal oversight.
Please apply directly with your update resume or call Moiz at 408-816-2442
Akraya, Inc. Is an award-winning staffing firm that works with many of the leading, technology-based companies around the world. We have been ranked as one of the “ Best Staffing Firms to Temp for” by Staffing Industry Analysts on multiple occasions and are a preferred staffing vendor within numerous staffing programs. Please visit akraya.Com to search through all of our current openings or to submit your resume to our recruiting team.