Principle Quality Engineer - Singapore - EA RECRUITMENT PTE. LTD.
Description
Well Established Company:
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Competitive Salary Range + AWS + Bonus Opportunities:
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Comprehensive Welfare Package and Career Development:
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Location: Boon Lay:
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Working Schedule: Monday to Friday:
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Work Hours: 8.30am to 5.30pm
Responsibilities:
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Ensure Compliance with ISO 13485:2016 and Other Relevant Standards:
- Conduct Continuous Improvements to the Quality Management System
Lead Internal and Customer Audits, Address Non-conformance Issues:
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Oversee Customer Projects and Quality Deliveries, Manage Product Quality, and Address Customer Complaints:
- Approve Release of Key Customer Products
- Manage CAPA, NCR, SCAR Processes and Conduct Root Cause Analysis
- Perform Risk Management, Validation, and Verification
Provide Training on QMS, Supplier Management, Design Control, and More
:
- Participate in Quality Objective and KPI Reviews
- Contribute to Quality Management Review
- Fulfill Any Other Assigned Duties
Job Requirements:
- Bachelor's Degree with at least 5 years of experience in quality management or risk assessment within the medical device sector
Certified Lead Auditor, Proficient in ISO 13485:2016 Internal Audits, Knowledge of ISO 14971:2019 and Relevant Standards
- Past Job Experiences and Responsibilities
- Salary Information
- Reasons for Job Change
- Availability Date
- Educational Background
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