9 days old

Quality Support 2 -ECO Document Coordinator

Walpole, MA
**Quality Support 2 -ECO Document Coordinator**

Locations:East Walpole, Massachusetts

Job Family: Quality Management


English (US)

**Job Description**

**Division:** Siemens Healthineers

**Business Unit:** Laboratory Diagnostics

**Requisition Number:** 219348

**Primary Location:** United States-Massachusetts-East Walpole

**Assignment Category:** Full-time regular

**Experience Level:** Entry level

**Education Required Level:** Associate's Degree / College Diploma

**Travel Required:** No

**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 worlds 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/healthineers

**Job Description:**

**Position Overview**

This is an individual contributor position that requires an individual with knowledge/experience utilizing document management systems and processes in a regulated environment, e.g., IVDD, Medical Device, Pharma, Biotech, etc. The individual in this role will be responsible for leading the effort to coordinate documentation update, translation and implementation activities among Siemens US cross functional team, Global Translation Service Team and China manufacturing facility. This position is based in Walpole, MA and reports into the China expansion Documentation Workstream Lead, also based in Walpole.


In this role the individual will be responsible for coordinating China document management activities.

Specific responsibilities include:

+ Coordinate document update activities with other project functions, e.g., Manufacturing, Technical Operations, Engineering, Quality, etc.

+ Review and update documents format before sending them for translation

+ Work closely with Translation Agency to monitor and track document translation progress to meet the project timeline

+ Assign and track technical review/confirm with other project function SMEs after the translation is done

+ Final release and implementation of translated documents in China

**Required Knowledge/Skills, Education, and Experience**

Experience: A minimum of 3-5 years in the medical device industry with at least 2 years in a role working in Documentation.

Education: A minimum of a 4 year degree is preferred, although a combination of education/experience will be considered.


+ Prior experience working in an FDA regulated environment.

+ Excellent verbal and written communication skills.

+ Prior experience with document management software, e.g., SAP, Documentum, Agile, etc.

+ 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. documentation system implementation.

+ Prior experience working with translation services.

+ Project management experience is a plus


**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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Quality Support 2 -ECO Document Coordinator

Walpole, MA

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Walpole, MA

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