What are the responsibilities and job description for the Supplier Quality Engineer position at TekOne IT Services Pvt. Ltd.?
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Job Description
Job Description
- Follow up on supplier audits to demonstrate supplier controls required by FDA CFR 820, ISO 13485, and ISO 9000.
- Work with suppliers to find solutions to identified problems.
- Create written reports and communicate results clearly and effectively to the auditee and Baxter management.
- Manage and ensure timely implementation of Supplier Corrective Action Reports (SCARs).
- Provide engineering support for nonconforming material (NMR) and Return Material Authorization (RMA) issues.
- Remediate supplier files to support current and business development activity related to the acquisition of new businesses.
- Remediate SNC Process.
- Verify supplier files are maintained and documented appropriately.
- Provide supplier metrics to management.
- Lead the supplier approval process by assessing manufacturing and quality systems capabilities and risks.
- Develop improvement plans for critical-to-quality suppliers.
- Manage personnel to maintain and reduce the incoming inspection cycle time.
- Establish problem-solving strategies and work with manufacturing and quality engineers to reduce MRB inventory.
- Perform component characteristic analysis to determine inspection status changes.
- Regulatory Knowledge:
- Knowledge of FDA CFR 820, ISO 13485, and ISO 9000 requirements.
- Quality Auditing Experience:
- Experience with quality auditing, specifically supplier audits.
- Problem-Solving Skills:
- Excellent problem-solving skills and analytical abilities.
- Communication Skills:
- Strong oral and written communication skills for effective reporting.
- Documentation Skills:
- Proficiency in creating comprehensive reports and maintaining accurate documentation.
- Supplier Management:
- Experience managing Supplier Corrective Action Reports (SCARs) and the supplier approval process.
- Engineering Support Experience:
- Ability to provide engineering support for NMR and RMA issues.
- Metrics Reporting:
- Experience in providing supplier metrics to management.
- Team Collaboration:
- Ability to work collaboratively with manufacturing and quality engineers.
- Lead Auditor Certification:
- ISO 13485 Lead Auditor certification is strongly desired.
- Education:
- B.S. Degree in Engineering required.
- Experience:
- 5 years of qualifying experience, including previous experience with quality auditing.
