(Senior) QMS Engineer

OVERVIEW:

The individual should be equipped with the good characteristics such as integrity, honesty, a break-through mindset, a high adversity quotient (good resilience and can work under pressure). In this position, you will collaborate with other cross functional team of NPI/NPD/ME/Testing to drive the quality improvement activities through the entire product life cycle (starting from product prototype to product end of life) and you will also leverage your experience and learning to positively impact the organization and meet our goals to deliver the 5 stars product to the consumers around the world.

Here are some of the EXCITING things you’ll get to do:

• Responsible for implementing and improving the medical device MFG quality system, ensuring its continued compliance with relevant requirements.

• Assist in the promotion and training of medical device QMS related standards.

• Assist suppliers in completing design transfer tasks to achieve mass production.

• Attend design transfer meetings and be responsible for implementing and improving the medical device production quality system, ensuring its compliance with relevant requirements.

• Manage and review batch records, process validation and related documents in the medical device production process.

• Evaluate the compliance and effectiveness of the quality system during the medical device development and MFG process, promptly provide feedback and quality improvement suggestions.

• Report on the operation of medical device MFG quality system and drive the resolution of MFG NCs.

• Complete other tasks assigned by leadership.

Position Requirements/ Experience:

• Bachelor's degree or above in Mechanical, Electrical, Electronic, Pharmaceutical or related fields.

• At least 5 years of experience in medical device or production quality systems, familiar with ISO 13485 quality system and medical device regulatory requirements, with experience in quality management system writing or implementation preferred.

• Excellent written communication skills and interpersonal skills, with good team collaboration spirit;

• Honest, trustworthy, meticulous, and serious.

• Able to adapt to long-term business trips (Ningbo, Xiamen, or Vietnam) for supplier system training or audits.

• Vietnam local person with English communication skill, or domestic person can accept long-time base on Vietnam will be preferred.