8 days old

Quality Engineer 4

Walpole, MA
**Quality Engineer 4**

Locations:East Walpole, Massachusetts

Job Family: Quality Management


English (US)

**Job Description**

**Division:** Siemens Healthineers

**Business Unit:** Laboratory Diagnostics

**Requisition Number:** 214300

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

**Assignment Category:** Full-time regular

**Experience Level:** Senior 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 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/healthcare

**Job Description:**

_Walpole Expansion Project Quality Lead_

**Position Overview**

This is a Senior Manager level position that will have quality oversight over all activities associated with a major expansion project at the Siemens Healthineers IVDD manufacturing facility in Walpole MA. The individual in this role will be responsible for ensuring compliance with global and site specific quality system requirements, as well as applicable external regulatory requirements. This position is based in Walpole, MA and has dual reporting into the Expansion Project Lead and the site Quality Head.


The primary responsibility for this position will be to provide overall direction for the quality assurance related activities associated with the expansion project, with a particular emphasis on Change Management, Risk Evaluation and Validation.

Specific responsibilities include:

+ Member of the Expansion Project Core Team

+ Identifying needs/gaps in human resources within the quality function and developing hiring plans accordingly

+ Will represent the project team at Change Review Board (CRB) and Validation Review Board (VRB) meetings

+ Project management for all Quality activities

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

Experience: A minimum of 10 years in the medical device or pharmaceutical/biotech industry with at least 3 years in a quality system management role. Prior IVDD experience highly desired.

Education: A minimum of a 4 year degree, preferably in an engineering or science discipline.


+ Excellent understanding and practical application of medical device quality system regulations, e.g., 21 CFR 820, ISO 13485 and ISO 14971.

+ Must be able to utilize a risk based approach when assessing the impact of change in order to develop appropriate validation strategies.

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

+ Prior experience with facility expansions is a plus

+ Must be able to work collaboratively with other Project Team members

+ Excellent written and verbal communication skills

+ Experience hosting/participating in FDA and Notified Body inspections

+ Prior experience in an IVDD manufacturing environment

**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 .


  • Biotechnology / Science
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  • Manufacturing / Production
  • Healthcare

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Quality Engineer 4

Walpole, MA

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Walpole, MA

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