Senior QMS Engineer

About Us 

SharkNinja is a global product design and technology company, with a diversified portfolio of 5-star rated lifestyle solutions that positively impact people’s lives in homes around the world. Powered by two trusted, global brands, Shark and Ninja, the company has a proven track record of bringing disruptive innovation to market, and developing one consumer product after another has allowed SharkNinja to enter multiple product categories, driving significant growth and market share gains. Headquartered in Needham, Massachusetts with more than 3,300+ associates, the company’s products are sold at key retailers, online and offline, and through distributors around the world.  

Our mission to positively impact people's lives every day in every home around the world allows our employees to be thinkers and tinkerers, designers and doers, creators and number crunchers, makers of things they love.  As we continue to grow, we are excited to add Senior QMS Engineer to our global team.

 

 

OVERVIEW:

Assists QA manager for medical device quality system and regulatory management in manufacture process.

 

 

LOCATION: Suzhou

 

 

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

 

Working Smart, Challenge and be challenge, Positive impact to the team,  Clear and clean at operations and proactive.

 

Accountabilities: 

Essential Functions

• Responsible for implementing and improving the medical device MFG quality system, ensuring its continued compliance with relevant requirements;
• 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 and related documents in the medical device production process;
• Report on the operation of the medical device MFG quality system and drive the resolution of MFG NCs;
• Evaluate the compliance and effectiveness of the quality system during the medical device MFG process, participate in internal audits and management reviews, promptly provide feedback and quality improvement suggestions;
• Assist in the promotion and training of medical device manufacture related regulations and product standards;
• Complete other tasks assigned by manager.

 

Hiring Requirements:

Experience: 

• Bachelor's degree or above in Mechanical, Electrical, Electronic, Pharmaceutical or related fields.
• At least 5 years of experience in medical device production quality systems, familiar with ISO 13485 quality system and medical device regulatory requirements, with experience in quality management system writing or implementation preferred
• Familiar with medical device system ISO13485, FDA, QSR820, independent promotion of the establishment and certification of medical system is preferred

 

 

Functional Skills/Knowledge

• Fluent in oral and written English. The communication capability of Chinese will be perfect.
• Quality system & regulation management background

• Assesses, coaches, and monitors the developments of supplier.

• Ability to work independently
• Be honest, loyal to the work,
• Strong code of ethics
• Can be traveling when necessary