Siemens Quality Manager (China Documentation Workstream Lead) in East Walpole, Massachusetts

Quality Manager (China Documentation Workstream Lead)

Locations:East Walpole, Massachusetts

Job Family: Quality Management

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English (US)

Job Description

Division: Siemens Healthineers

Business Unit: Laboratory Diagnostics

Requisition Number: 205440

Primary Location: United States-Massachusetts-East Walpole

Assignment Category: Full-time regular

Experience Level: Mid level

Education Required Level: Bachelor's Degree

Travel Required: 10%

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/healthineers

Job Description:

Position Overview

This is a Manager level 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 establish a document management system in a new IVDD manufacturing site to be built in China, and includes the management of the document translation process. This position is based in Walpole, MA and reports into the China expansion project Core Team Quality Lead, also based in Walpole.

Responsibilities

In this role the individual will be responsible for implementation of the China document management process and contracting with a Translation Agency to provide document translation services. Will work closely with the other project core team leads/functions, e.g., Manufacturing, Technical Operations, Engineering, Quality, etc., to coordinate the translation of procedures.

Specific responsibilities include:

  • Member of the China Project Core Team.

  • Determining staffing/resource needs for the US based Documentation Workstream.

  • Training of applicable personnel.

  • Will require some travel to China.

Required Knowledge/Skills, Education, and Experience

Experience: A minimum of 10 years in the medical device industry with at least 3 years in a supervisory/management role working in Documentation.

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

Skills/Knowledge/Experience:

  • 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

**LI-BAM

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 .