Senior QMS Engineer
Senior QMS Engineer
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Job Description
About Us
SharkNinja is a global product design and technology company with a diversified portfolio of 5star rated lifestyle solutions that positively impact peoples lives in homes around the world. 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 3300 associates the companys 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 youll 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:
- Bachelors 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 dont just raise the barwe 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 youll 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 whats possible. When you join youre not just part of a companyyoure part of an outrageously extraordinary community. Together we wont just launch productswell 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 SharkNinjas 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
SharkNinjas Candidate Privacy Notice can be found here:
For candidates based in China please visit: https://sharkninja/candidateprivacynotice/china/
For candidates based in Vietnam please visit:
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
Required Experience:
Senior IC
Employment Type
Full-Time
