Product Quality Engineer

Hi,

My name is Karthik Mutyala, from Stark Pharma Solutions Inc, we are hiring talents for our client. I am working on Product Quality Engineer right now. Please send me your updated resume if you have relevant experience and interested in this position. The detailed job description is as follows

Position: Product Quality Engineer

Location: Remote

Duration: Long Term Contract

Job Overview

We are seeking an experienced Product Quality Engineer to support quality engineering activities for electro-mechanical medical devices involving both hardware and software. The ideal candidate will have strong experience investigating product failures, driving root cause analysis, and implementing corrective actions within a regulated medical device environment.

Key Responsibilities

• Investigate product failures and perform root cause analysis.
• Support CAPA, non-conformance, and complaint investigations.
• Collaborate with Design, Manufacturing, Software, Hardware, and Quality teams to resolve product issues.
• Analyze product performance data and recommend quality improvements.
• Ensure compliance with FDA, ISO 13485, and medical device quality standards.
• Support risk management and continuous improvement initiatives.
  
  

Required Qualifications

• Bachelor's degree in Engineering or a related field.
• 5+ years of Product Quality Engineering experience in the medical device industry.
• Experience with electro-mechanical devices involving hardware and software.
• Strong knowledge of failure investigations, CAPA, root cause analysis, and risk management.
• Familiarity with FDA regulations and ISO 13485.
  
  

I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with the best number and time to reach you.

Please follow Stark Pharma Solutions on LinkedIn for the latest job updates: https://www.linkedin.com/company/99455976/

Thank you,

Karthik Mutyala

Recruiting Manager

Stark Pharma Solutions Inc

Email: [email protected]

15 Corporate Place S, Suite 350,

Piscataway, New Jersey 08854

www.starkpharma.com