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Quasar Medical (Thailand) Co., Ltd.

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Nov 27, 2024

Quality Engineer

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WHA Chonburi Industrial Estate 1 Chon Buri

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Job Descriptions
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.
Qualifications
  1. Bachelor's degree in engineering or science
  2. At least four years of relevant experience in Quality Control (QC) / Quality Assurance (QA) or related roles within the medical device sector.
  3. Knowledge of QC-7tools, PFMEA, APQP, PPAP, 8D, SPC, 5Why, etc.
  4. Can use the basic measurement device
  5. Demonstrated excellence in problem-solving, critical judgment, and decision-making abilities. Comprehensive knowledge of quality control tools, methodologies, and best practices is essential.
  6. 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.
  7. Proficient in English, both written and verbal, facilitating effective communication across various teams and stakeholders.
  8. Strong capabilities in utilizing Microsoft Office applications and other relevant software for quality management and reporting.
How to apply
- สมัครผ่านอีเมล - สมัครผ่าน Jobthai
Contacts
คุณภวิศา กุลราช
Quasar Medical (Thailand) Co., Ltd.
340/1 หมู่ที่ 6 WHA Chonburi Industrial Estate 1
Bo Win Si Racha Chon Buri 20110
Tel. : 038-111-709 ต่อ 308
Email : quasar-med_12@trustmail.jobthai.com (Email for job application & inquiry)
Location
WHA Chonburi Industrial Estate 1
Bo Win Si Racha Chon Buri
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