Quality Engineer: Bac Ninh, Yen Phong expansion industrial park
AP Technologies
Location: Gmap link
Roles & Responsibilities
- Assist in establishing, implementing, and maintaining the Quality Management System to ensure compliance with relevant standards and regulations.
- 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 criteria.
- Monitor quality control processes during production to ensure products meet design and/or customer specifications.
- Responsible for non-conforming product handling, root cause investigation and corrective/preventative actions, together with effectiveness checking.
- 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.
- Drive change management and control
- Authorize the release (COC) of products, COA review and approval
- Monthly data analysis on product quality metrics and quality objective
- Review and approval on DHR
- Any other duties as assigned from time to time.
Job Requirements
- 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.
- Proficient in two languages: English, Chinese,
- 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.
- Proficiency in office software, with the ability to draft and edit technical reports.
- Excellent communication and teamwork skills, able to liaise effectively with different departments and levels.
About AP-TECHNOLOGIES
- AP Technologies is a multinational medical device contract manufacturer (Head office in Singapore) that specializes in tight tolerance, precision medical components using the latest extrusion and molding processes. We utilize our comprehensive quality control system, state-of-the-art facility, and advanced statistical methodologies to maintain the highest quality standards in the industry.
- Vietnamese Company size: 100 – 200 staffs
