FUJIFILM

Quality Engineer II

Job Locations US-WA-Seattle
Posted Date 1 week ago(10/20/2021 8:18 PM)
Requisition ID
2021-15317
Category
Regulatory/Compliance
Company (Portal Searching)
FUJIFILM Sonosite

Overview

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FUJIFILM, Sonosite, Inc . We are an innovative and high performance culture with tremendous opportunities. People who work here are given the unique opportunity to contribute to the advancement of healthcare throughout the world. Headquartered in Bothell, WA USA, Fujifilm Sonosite is represented by a global distribution network in over 100 countries. Since its inception, Fujifilm Sonosite’s lightweight, robust products have created and led the point-of-care ultrasound market. From sophisticated urban hospital emergency rooms to clinics in austere, remote villages, Fujifilm Sonosite systems are used by over 21 medical specialties and provide clinicians around the world with a cost-effective tool for improving patient safety and workflow efficiency. Fujifilm Sonosite holds a number of prestigious design awards and has in excess of 145 patents.

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Job Summary:

The Quality Engineer II is responsible for assisting in establishing, implementing and maintaining systems and/or services to measure and improve product quality, cost, and customer service while ensuring full compliance to FDA and applicable ISO requirements. The Quality Engineer II will be responsible for driving activity around process validation, as well as participating in establishing and monitoring systems related to Inspection, Testing, Training, Supplier Qualification, New Product Introduction, Manufacturing, Complaints, and Corrective/Preventative Action. 

 

Essential Job Functions:

  • The Quality Engineer will be innovative, knowledgeable and intensely committed to ensure that products we supply conform to the FDA Quality System Regulation and ISO 13485.
  • Understands and is capable of implementing standard approaches to problem solving and prevention.  Devises creative approaches to solving problems encountered.
  • Support new product development in ensuring compliance with Quality System requirements.  Review/approve engineering changes on behalf of QA.
  • Partner with R&D and Operations in the development of verification and validation protocols for product designs and manufacturing processes.
  • Identify, plan and participate in the implementation of process improvements.
  • Support Risk Management activities including Failure Mode and Effects Analysis.
  • Support the MRB process for discrepant material investigations and decisions.
  • Support supplier qualification and monitoring.
  • Review complex complaints and complaint trends, and assist in failure investigations.
  • Support development and continuous improvement of quality system procedures.
  • Report to management on quality issues and trends.

Knowledge and Experience:

  • BS or MS degree in Mechanical/Electrical/Industrial Engineering.
  • At least 2 years of experience working within the Quality organization of a Medical Device Manufacturer.
  • Applications of Lean principles such as Value Stream Mapping, Standard Work, 5S, Kaizen desired.
  • Experience with domestic and overseas manufacturing and working directly with Contract Manufacturers and strategic vendors.
  • Experience with product lifecycle management (P/N creation, BoM creation, ECO generation and management, AVL management, etc.).
  • Quality engineering background and experience with AQLs, product inspections, vendor qualifications and audits.

Skills and Abilities:

  • Ability to travel 5% domestically and internationally as needed, sometimes on short notice.
  • Proficient in MS Office programs (Word, Excel, PowerPoint), Visio, MS Project; experience with document templates and scientific reference software is desirable.
  • Must be detail-oriented with strong written and oral communication skills.

 

FUJIFILM Sonosite, Inc. offers a fantastic compensation package, including benefits, and a 401k program. Visit us today to learn more about our exciting technologies and how you can make a difference. To apply and obtain further details regarding key responsibilities and experience requirements, check out our careers page at   www.sonosite.com/about/careers                                                  

FUJIFILM Sonosite, Inc.   is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age, protected veteran status, disability status, or any other characteristic protected by law.           

                                                                                          

In compliance with the ADA Amendments Act, should you have a disability that requires assistance and / or reasonable accommodation with the job application process, please contact the Human Resources department via phone at 425-951-1200, or via e-mail at ffss-hr@fujifilm.com .  Additionally, the affirmative program/plan is available for review upon formal request by employees and applicants for employment in the Human Resources office during regular office hours.                                                                                                                                                                          

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