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.

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

Our Culture

At SharkNinja, we don’t just raise the bar—we push past it every single day. Our Outrageously Extraordinary mindset drives us to tackle the impossible, push boundaries, and deliver results that others only dream of. If you thrive on breaking out of your swim lane, you’ll be right at home.

What We Offer

We offer competitive health insurance, retirement plans, paid time off, employee stock purchase options, wellness programs, SharkNinja product discounts, and more. We empower your personal and professional growth with high impact Learning Programs featuring bold voices redefining what’s possible. When you join, you’re not just part of a company—you’re part of an outrageously extraordinary community. Together, we won’t just launch products—we’ll disrupt entire markets.

At SharkNinja, Diversity, Equity, and Inclusion are vital to our global success. Valuing each unique voice and blending all of our diverse skills strengthens SharkNinja’s innovation every day. We support ALL associates in bringing their authentic selves to work, making an impact, and having the opportunity for career acceleration. With help from our leadership, associates, and our community, we aim to have equity be a key component of the SharkNinja DNA.

Learn more about us: Life At SharkNinja Outrageously Extraordinary

SharkNinja's Candidate Privacy Notice can be found here: https://www.sharkninja.com/candidate-privacy-notice/

For candidates based in China, please visit: https://sharkninja.com/candidate-privacy-notice/china/

For candidates based in Vietnam, please visit: https://www.sharkninja.com/candidate-privacy-notice/vietnam/

We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, disability, or any other class protected by legislation, and local law. SharkNinja will consider reasonable accommodations consistent with legislation, and local law. If you require a reasonable accommodation to participate in the job application or interview process, please contact SharkNinja People & Culture at accommodations@sharkninja.com