What are the responsibilities and job description for the Supplier Quality Engineer position at Intellectt Inc?
Job Summary:
We are seeking an experienced Supplier Quality Engineer to support a medical device remediation project. The ideal candidate will have strong expertise in supplier quality management, injection molding processes, and quality system remediation activities, including NCMRs, SCARs, and CAPAs.
Key Responsibilities:
- Lead supplier quality remediation activities within a regulated medical device environment.
- Manage and investigate NCMRs, SCARs, CAPAs, and supplier-related quality issues.
- Support supplier quality operations for injection molding suppliers and components.
- Develop, organize, and maintain supplier quality documentation and records.
- Collaborate with suppliers and cross-functional teams to drive corrective and preventive actions.
- Ensure compliance with FDA, ISO 13485, and company quality requirements.
Qualifications:
- 5 years of Supplier Quality Engineering experience in the medical device industry.
- Proven experience supporting QMS remediation projects from a Supplier Quality perspective.
- Strong background handling NCMRs, SCARs, CAPAs, and supplier investigations.
- Experience managing supplier quality activities related to injection molding.
- Excellent documentation, auditing, and problem-solving skills.
Preferred Skills:
- Medical device remediation experience.
- Supplier auditing and qualification experience.
- Knowledge of FDA QSR and ISO 13485 requirements.