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Quality Assurance Assistant Engineer
2 months ago
Job Title
Assistant Engineer, QAJob Overview
Position: Assistant Engineer, QA
Location: Shenzhen
Objective:
- Independently address internal and customer feedback regarding quality issues, effectively reducing customer rejection rates.
- Oversee the quality requirements during the transition of new projects to production, ensuring smooth transfer and compliance with regulations and quality standards.
- Ensure continuous improvement in product quality post-transition, verifying that production molds and equipment are validated.
Main Responsibilities:
- Coordinate all quality requirements prior to the production of new products.
- Facilitate the fulfillment of various quality demands and enhancement of quality systems before and after product registration.
- Implement product risk management and analysis, creating documentation to ensure product quality meets customer expectations while effectively preventing and controlling any risks, ensuring safety, efficacy, and high reliability.
- Manage process changes and ensure all documentation and samples are correctly updated throughout the change process.
- Complete relevant process confirmations and validations of special procedures and equipment to ensure normal production and smooth transitions, adhering to regulatory requirements.
- Establish measurement methods for new projects and confirm the repeatability and reproducibility of measurements.
- Drive process improvement initiatives to achieve target internal rejection rates for finished products.
- Conduct market feedback analysis to ensure a continuous reduction in return rates for key products.
- Provide technical support and methodologies to assist production lines in effectively controlling quality and continuously reducing quality control costs.
- Independently manage internal and customer feedback regarding quality issues, addressing customer complaints promptly and ensuring the effectiveness of corrective actions.
Qualifications and Experience:
- Education: Bachelor’s degree or equivalent.
- Experience: 0-2 years of quality-related experience for Bachelor’s degree holders; 2+ years for those with a diploma.
- Skills: Familiarity with ISO13485 standards and FDA 21 CFR 820 QSR regulations, understanding of various regional quality system requirements, and experience in establishing and maintaining quality systems.
- Proficient in QC seven basic tools and capable of utilizing various quality control instruments.
- Ability to read and write in English.
- Strong communication skills.
About Philips
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