27 days old

Senior Quality Engineer

Walpole, MA
**Senior Quality Engineer**

Locations:East Walpole, Massachusetts

Job Family: Quality Management


English (US)

**Job Description**

**Division:** Siemens Healthineers

**Business Unit:** Laboratory Diagnostics

**Requisition Number:** 219230

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

**Assignment Category:** Full-time regular

**Experience Level:** Senior level

**Education Required Level:** Bachelor's Degree

**Travel Required:** 5%

**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 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.

**Job Description:**

**Siemens US Talent Acquisition**

**Position Overview**

An experienced senior level Quality Engineering position at Walpole, which is involved in developing, implementing, maintaining, and improving systems to ensure products are designed and produced to meet or exceed customer requirements and expectations. The candidate ensures consistent implementation and compliance to the Siemens Healthcare Diagnostics Quality System and external regulations including, but not limited to, the FDA Quality System Regulation (21 CFR Part 820), ISO 13485 and In-Vitro Diagnostics Directive (IVDD).


+ Quality Engineer (QE) establishes the principles of product quality evaluation and control for the system.

+ The QE provides independent oversight and review of the project deliverables throughout the lifecycle; participates in the change management process to ensure the products continue to meet customer requirements; and is part of a cross-functional team with other business and engineering disciplines.

+ The Walpole QEs work-scope includes Quality Engineering support for the Design Control, Process Validation and Control, and Risk Management Process.

+ The main functions of the QE also include acting as the quality representative on the element team during technical transfer from design to manufacturing and to support changes going forward after manufacturing has commenced.

+ The individual is a team player participating on design transfer project teams to provide leadership in the design control, process validation and control, and risk management process in a class II and class III IVD reagent manufacturing facility. Challenges include working among different business units within the company.

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

BS in Life Science or Engineering discipline with a minimum of 5 years of experience in the medical device, pharmaceutical or biotechnology industry.

Strong knowledge of FDA Quality System Regulation (QSR) with an emphasis on Process Validation and Design Controls; ISO 13485; and ISO14971.

Proven experience providing quality engineering leadership to project teams in the areas of Design Controls, Process Validation and Control, and Risk Management.

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

Trained on Quality System Regulation, Process Validation or Design Control course

Experienced with New Product Development, Equipment Qualification and Process Validation

ASQ Certified Quality Engineer

Demonstrated and applied a broad knowledge of field of specialization through successful completion of moderately complex assignments

**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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Walpole, MA

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Walpole, MA

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