What are the responsibilities and job description for the Quality Engineer / Supplier quality Engineer position at TekOne IT Services Pvt. Ltd.?
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.
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.
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.
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).
Qualifications
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.
Key Skills
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.
Preferred Skills
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).
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