Senior Supplier Quality Engineer – Medical Device Remediation

Stark Pharma Solutions Inc; Bridgeport (CT); On-site; USD 85,000 - 110,000; Full time

Job summary

Stark Pharma Solutions Inc is seeking an experienced Supplier Quality Engineer to support quality remediation initiatives in the medical device sector. The role involves managing supplier-related quality issues, overseeing investigations, and ensuring compliance with regulatory standards.

The ideal candidate will have at least 7 years of experience in supplier quality engineering and prove strong capabilities in managing NCMRs, SCARs, and CAPAs. This position offers a 6-month contract located in the Bridgeport Area, CT.

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.

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.

Skills

Supplier Quality Engineering

Quality System Remediation

NCMRs

SCARs

CAPAs

Regulatory Compliance

Problem-solving

Job description

Stark Pharma Solutions Inc is seeking an experienced Supplier Quality Engineer to support quality remediation initiatives in the medical device sector. The role involves managing supplier-related quality issues, overseeing investigations, and ensuring compliance with regulatory standards.

The ideal candidate will have at least 7 years of experience in supplier quality engineering and prove strong capabilities in managing NCMRs, SCARs, and CAPAs. This position offers a 6-month contract located in the Bridgeport Area, CT.