Siemens Careers

Quality Engineer 3

Issaquah, Washington
Quality Management

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English (US)

Job Description

Division: Siemens Healthineers
Business Unit: Ultrasound
Requisition Number: 232434
Primary Location: United States-Washington-Issaquah
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 10%

Division Description:

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Job Description:


Position Overview

"Is it time in your career to join a united team who strives for excellence?"

 

Medical Device regulations require a systematic approach for post-market surveillance. The position has responsibility for all aspects of complaint management for Class II imaging devices. It requires solid comprehension of and strong experience with FDA 21 CFR 820, 803, MEDDEV and ISO13485 post market surveillance requirements and experience in system implementation. It will:

  • Ensure compliance with all post market activities including complaint processing and investigations
  • Coordinate with other aspects of the Quality Management System such as Risk Management, CAPAs and field corrective actions
  • Stay current with applicable regulations, quality standards/systems for all company products and markets
  • Maintain a global perspective on all medical device regulations and incorporate them into daily execution

Responsibilities

The responsibilities associated with this position include:

  • Represent the Quality department with compliant practices and guidance to those seeking advice
  • Determine safety classification and 21 CFR 803 and Vigilance reporting of incoming complaints
  • Process complaint investigations to ensure compliance with Regulations and internal Siemens’ processes
  • Interact with a cross-functional team of department representatives such as Engineering, Regulatory and Service
  • Facilitate activities required to meet Siemens’ targets for complaint closure rates
  • Manage a variety of projects all at varying levels of completion
  • Oversee responsibility for an ultrasound product or product line which may support intra-cardiac imaging catheters.

 

Required Knowledge/Skills, Education, and Experience

  • Bachelor of Science degree required
  • Experience with complaint handling required (4 years’ experience)
  • Work experience in Medical Device required (3 years’ experience)
  • 10% travel required 

 

 

Preferred Knowledge/Skills, Education, and Experience

  • Experience with filing eMDRs preferred
  • Clinical experience or knowledge in patient care or medical procedures is beneficial. Experience or knowledge of Ultrasound is excellent.
  • Strong time management skills
  • Effective writing and communication skills
  • Strong desire for critical thinking skills, problem solving and attention to detail

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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.

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



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