Job Description

Quality Engineer

Our client, a leading Medical manufacturing company, is looking for a Quality Engineer. This is for an initial duration of 06 months and is located at San Jose, CA. Job Title: Quality Engineer Reference ID: 26-04281 Location: San Jose, CA Duration: 06 months Job Type: Contract (Candidates must be able to work on W2 without VISA sponsorship)

Job Title: Quality Engineer Department: Quality and Regulatory Affairs Location: 100% onsite at Duncan, South Carolina

Top 3 Skills

• Technical writing experience need to be able to document clearly
• Experience in Quality
• Will be hands on position
• Clean room environment - will need to be able to do full gown up daily for clean room to assist team to resolve issues.

What You'll Do

• Support manufacturing cross functional team as a Quality Engineer in day-to-day production activities and daily management in Cleanroom environment.
• Implement and maintain, as a team member, Standard Operating Procedures, Process flow charts, Process Control Plans, Process FMEA, and Validations.
• Manage Non-conformance, CAPA and Complaint (internal and external) processes; ensure root cause analysis and effectively implement robust action plans. Follow-up and verification of CAPAs to ensure no recurrence. Facilitate the closures of these in a timely manner.
• Provide Manufacturing Quality Trend Charts/Analysis and suggest/implement continuous improvement practices, including appropriate kaizen events on relevant processes based on trends. Support shin Kaizen events and use Lean manufacturing principles, as and when required. Roll out CDT&R, VOP, DRS, PSP, FMEA- utilize DBS to drive continuous improvements.
• Support Supplier Quality Engineer for driving improvements for Supplier related issues (SCARs), work closely with Purchasing/Sourcing departments to select/maintain/drop suppliers list based on their performance.

Who You Are

• Bachelor's degree in an engineering field (e.g. Biomedical, Chemical, Pharma, Industrial, Mechanical, Systems, Quality, Reliability) or equivalent work experience.
• At least 3 years of experience on a manufacturing or relevant environment
• Understands and applies Lean Six Sigma tools for problem solving, risk assessment, and process control.
• Proficient with Microsoft Office Tools (including Outlook, Teams, Excel, and Word).

Interested and qualified candidates, please send your most recently updated word document resume to Jaffer.s@sunrisesys.com or Pavan.P@sunriseysys.com

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