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Quality Assurance Engineer 2

Quality Assurance Engineer 2
Locations:East Walpole, Massachusetts
Job Family: Quality Management
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Job Description
Division: Siemens Healthineers
Business Unit: Laboratory Diagnostics
Requisition Number: 218155
Primary Location: United States-Massachusetts-East Walpole
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 15%
Division Description:
Division Description
Siemens is a global technology powerhouse that has stood for engineering excellence, innovation, quality, reliability and internationality for more than 165 years. As a global technology company, Siemens is rigorously leveraging the advantages that this setup provides. To tap business opportunities in both new and established markets, the Company is organized in nine Divisions: Power and Gas, Wind Power and Renewables, Energy Management, Building Technologies, Mobility, Digital Factory, Process Industries and Drives, Healthineers and Financial Services.
With 45,000 employees Siemens Healthineers is one of the world?s largest suppliers of technology to the healthcare industry and a leader in medical imaging, laboratory diagnostics and healthcare IT. All supported by a comprehensive portfolio of clinical consulting, training, and services available across the globe and tailored to customers? needs. So that more people can have a life that is longer, richer, and more filled with happiness.
For more information, please visit: http://www.usa.siemens.com/healthcare
Job Description:
Position Overview
This is an individual contributor position that requires an individual with extensive knowledge of medical device quality system regulations (i.e. FDA?s Quality System Regulation and ISO 13485) and the ability to develop, implement and maintain a quality system compliant with these requirements for a new facility to be built in China. This position is based in Walpole, MA and reports into the China expansion QA manager, also based in Walpole.
Responsibilities
The primary responsibility for this role will be assisting QA manager and Core Team Quality Lead with the development and implementation of the China facility Quality System. The QA engineer will also provide supports on China risk management files, DHFs, and DMR transfer activities.
Specific responsibilities include:
+ Member of the China Project extended team.
+ Integration of Siemens Healthineers global and local quality system requirements into a China facility quality system that is compliant with CFDA requirements, with an emphasis on the following QS processes:
+ CAPA
+ Internal audit
+ Change Management
+ Risk management
+ Supplier Quality management
+ Management Review
+ DHR review
+ QA Release
+ Provide support to the China Quality team to ensure that the Quality Management System is fully implemented in the organization.
+ Assist in risk management files, DMR, DHFs for identified products.
+ Participation in the training of China based personnel during visits to the Walpole site.
+ May require some travel to China.
Required Knowledge/Skills, Education, and Experience
Experience: A minimum of 3 - 5 years in the medical device industry / pharma /biotech
Education: A minimum of a 4 year degree is required.
Skills/Knowledge/Experience:
+ Excellent understanding and practical application of medical device quality system regulations including CFR 21 Part 820 (QSR), ISO 13485, , and other domestic and international regulations that may apply
+ Prior experience working in an FDA regulated environment.
+ Excellent verbal and written communication skills.
+ Must be able to work collaboratively with other project team members.
Preferred Knowledge/Skills, Education, and Experience
+ Prior experience with facility start-ups, or other major projects, e.g. quality system remediation efforts or deployment projects.
+ A quality engineering certification from the American Society for Quality other qualifying organization is preferred. Examples include the CQA, CQE, CRE, etc.
+ Fluent in Mandarin is a plus
+ Knowledge of CFDA IVD GMP requirements
Equal Employment Opportunity Statement
Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protected veteran or military status, and other categories protected by federal, state or local law.
EEO is the Law
Applicants and employees are protected under Federal law from discrimination. To learn more, Click here at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm .
Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here at https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf .


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