Supplier Quality Engineer

Hi,

My name is Karthik Mutyala, and I am a Recruitment Manager with Stark Pharma Solutions, specializing in opportunities across the Pharmaceutical, Biotechnology, Medical Device, and Life Sciences industries.

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.

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https://www.linkedin.com/company/99455976/

Role: Supplier Quality Engineer

Location: Bridgeport Area, CT

Duration: 6-Month Contract

Position Overview

We are seeking experienced Supplier Quality Engineers to support a medical device quality remediation initiative. This role will focus on supplier quality operations, remediation activities, quality system improvements, and supplier performance management within a regulated medical device environment.

The ideal candidate will have a strong background in supplier quality engineering, remediation projects, injection molding suppliers, and quality system processes including NCMRs, SCARs, and CAPAs.

Key Responsibilities

• Support supplier quality remediation activities within a medical device manufacturing environment.
• Lead and manage supplier-related quality investigations, nonconformances, and corrective action initiatives.
• Review, develop, and maintain Supplier Quality documentation and records.
• Drive closure of supplier quality issues through effective root cause analysis and corrective actions.
• Manage and support:
• Nonconforming Material Reports (NCMRs)
• Supplier Corrective Action Requests (SCARs)
• Corrective and Preventive Actions (CAPAs)
• Collaborate with suppliers to improve quality performance and ensure compliance with regulatory requirements.
• Support supplier qualification, monitoring, and ongoing quality improvement initiatives.
• Partner with cross-functional teams including Quality, Manufacturing, Engineering, and Supply Chain.
• Ensure supplier quality processes align with QMS requirements and remediation objectives.
• Organize and maintain supplier quality documentation to support audit readiness and compliance efforts.
  
  

Required Qualifications

• 7 years of Supplier Quality Engineering experience within the Medical Device industry.
• Proven experience supporting Quality System remediation projects from a Supplier Quality perspective.
• Hands-on experience managing NCMRs, SCARs, CAPAs, and supplier quality investigations.
• Strong understanding of FDA Quality System Regulations and ISO 13485 requirements.
• Experience working with injection molding suppliers and manufacturing processes.
• Demonstrated experience developing, reviewing, and maintaining supplier quality documentation.
• Strong problem-solving, root cause analysis, and communication skills.