Siemens Careers

Senior Quality Engineer- IVD/ Medical Device

East Walpole, Massachusetts
Quality Management

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English (US)

Job Description

Division: Siemens Healthineers
Business Unit: Laboratory Diagnostics
Requisition Number: 236789
Primary Location: United States-Massachusetts-East Walpole
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 5%

Division Description:

 
At Siemens Healthineers, we are passionate about enabling healthcare professionals to deliver high quality patient care, and to do so affordably.  A leading global healthcare company, Siemens Healthineers continues to strengthen our portfolio of medical imaging and laboratory diagnostics, while adding new offerings such as managed services, consulting, and healthcare IT services – as well as further technologies in the growing market for therapeutic and molecular diagnostics.
 
Siemens Healthineers develops innovations that support better patient outcomes with greater efficiencies, giving providers the confidence they need to meet the clinical, operational and financial challenges of a changing healthcare landscape.
 


Job Description:

Siemens US Talent Acquisition


Position Overview

An experienced mid-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).

 

Responsibilities

  • 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 QE’s work-scope includes Quality Engineering support for the Design Changes, Process Changes, New Product Design Transfer, Process Validation, 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; Design Control; ISO 13485; and ISO14971.

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

Preferred Knowledge/Skills, Education, and Experience

·       Trained on Quality System Regulation, Process Validation, Risk Management 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.

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Applicants and employees are protected under Federal law from discrimination. To learn more, Click here.

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Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here.



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