Tuyển dụng Senior Quality Engineer/ QMS - Medical Devices tại Bắc Ninh

• Assist in establishing, implementing, and maintaining the Quality Management System to ensure compliance with relevant standards, regulations and customer requirements.
• Participate in internal, and external audits and customer audit, identify improvement opportunities, and follow up on corrective actions.
•  Responsible for product transfer from China facility to Vietnam and responsible for the quality section training to QC supervisor, QC inspections at the Vietnam facility. And responsible for the assessment to ensure the QC team is familiar with the specific product quality and control requirements.
• Responsible for the assessment and review of supplier qualification, performance, and process capability. Cooperate with procurement and suppliers on quality improvement. Responsible for supplier issues handling, analysis, and improvement.
• Collaborate in new product transfer by defining and reviewing product quality standards and inspection protocols.
• Involve in product transfer and validation activities, and responsible for the quality documents are created and maintained up to date. E.g. process follow, risk management, quality control plan, DMR, create the inspection criterias, etc.
• Monitor quality control processes during production to ensure products meet design and/or customer specifications.
•   Responsible for customer complaint handling, cooperating with relevant teams on root cause analysis, action plan, and customer response. Maintain good communication with customers on quality improvement

Yêu cầu ứng viên

• Diploma or Bachelor’s degree in Mechanical, Electronics, Materials, or related Engineering fields.
•  At least 3 years’ experience in medical device supplier and process quality control.
• Languages: English,Good.
• Proficient in quality management tools and methodologies (e.g., APQP, PPAP, MSA, SPC)
• ISO 13485:2016 certified internal auditor will be advantageous
• Strong analytical and problem-solving skills, capable of conducting root cause analysis and proposing improvement plans

Quyền lợi được hưởng

• Full salary-based social insurance (BHXH) contribution
• Monday – Friday working schedule
• 100% salary during probation
• Clean, modern and professional working environment