Position Details
Quality Engineer Supplier Quality Engineer Apply
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Supplier Quality Management:
- Ensure suppliers meet all regulatory requirements and quality standards.
- Create and maintain supplier performance databases.
- Oversee and assess products and materials from vendors to ensure they meet quality expectations.
- Act as a liaison between vendors and company leadership to address quality issues and provide solutions.
- Collaborate with suppliers to reduce defect rates and improve product quality.
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Quality Control and Process Improvement:
- Develop and implement quality control guidelines and protocols.
- Perform logistics tasks such as coordinating with vendors when supplies fail to meet standards.
- Conduct on-site inspections of supplier facilities to ensure adherence to company quality standards.
- Provide support in root cause analysis, corrective actions, and process improvements to increase First-Time-Through (FTT) rate.
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Support Manufacturing Processes:
- Ensure all processes comply with established company and regulatory standards.
- Ensure validation documentation (PSW, PPAP, IQ/OQ/PQ) is completed before lift and shift activities.
- Monitor the transfer of production processes to ensure a 95% FTT rate at the receiving site after installation, validation, and run-off.
- Identify and resolve process issues, field complaints, and downtime related to quality to improve site productivity.
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Supplier Localization & Transfer Support:
- Support localization of parts at the receiving site by working closely with vendors to ensure quality control in alignment with company policies.
- Manage supplier transfers and support vendor management to ensure compliance with Acceptable Quality Levels (AQLs).
- Education: Bachelor's degree in Engineering, Quality Management, or related field.
- Experience: Minimum 5 years of experience in supplier quality, process improvement, or manufacturing, preferably within a regulated industry (e.g., medical devices, automotive).
- Certifications: Six Sigma, Lean Manufacturing, or other quality-related certifications are preferred.
- Supplier Quality Management: Experience working with vendors and suppliers to ensure product quality and adherence to regulations.
- Quality Control & Compliance: Expertise in quality control, process validation, and familiarity with PSW, PPAP, IQ/OQ/PQ processes.
- Problem-Solving & Process Improvement: Strong skills in root cause analysis, corrective actions, and continuous improvement methodologies (Six Sigma, Lean, etc.).
- Software Proficiency: Strong computer skills, including Microsoft Office and quality management software.
- Communication: Excellent verbal and written communication skills for interacting with vendors, cross-functional teams, and senior management.
- Experience with Process Failure Mode Effects Analysis (PFMEA), Control Plans, and other quality assurance tools.
- Familiarity with ISO standards and FDA regulations.
- Experience in project management and process transfers (lift and shift).
