Quality Engineer

Job summary:

Monitor product quality; implement quality control (IPQC, PSA) and improvement；

To achieve product quality targets. Lead New project introduction (NPI project) in quality activities.

Lead workshop improvement activities to improve product quality.

Responsibilities:

• Lead project team on new project quality improvement before mass production
• Participate new products trail run, follow the products quality and gave personal advice from quality view.
• To be quality contact window with customer on new project quality, Lead new project gate review and quality risk assessment
• Establish the requirements of measurement & testing and follow up the implementation, include appropriate SPC control, Data collection and analysis management
• Review product manufacturing environment requirements. Setup visual specifications, including sampling plan of Incoming inspection (IQC), In-process inspection (IPQC) and Final Inspection (PSA)
• Lead to resolve customer quality issues, analyze and handle material quality issue and follow up corrective action.
• Audit the production line according to audit plan.
• Establish, maintain and improve the work instruction, inspection check list and training to inspectors
• Participate in Validation process and Internal Audit according to ISO 13485.
• CME & CDA validation, CME & OFA monthly monitoring and report.
• Prepare all Quality report, FAI report and inspection report as per customer requirement.

Qualification:

• Bachelor's degree in engineering or science
• At least four years of relevant experience in Quality Control (QC) / Quality Assurance (QA) or related roles within the medical device sector.
• Knowledge of QC-7tools, PFMEA, APQP, PPAP, 8D, SPC, 5Why, etc.
• Can use the basic measurement device
• Demonstrated excellence in problem-solving, critical judgment, and decision-making abilities. Comprehensive knowledge of quality control tools, methodologies, and best practices is essential.
• Proven experience or familiarity with quality system requirements for regulated products, including but not limited to ISO 13485, FDA Quality System Regulations, ISO 14971, and relevant international standards.
• Proficient in English, both written and verbal, facilitating effective communication across various teams and stakeholders.
• Strong capabilities in utilizing Microsoft Office applications and other relevant software for quality management and reporting.

Benefit:

• 5 days working
• Fixed Bonus
• Variable Bonus
• Provident fund
• Group insurance