Quality Assurance Coordinator

We are seeking a highly skilled and experienced Quality Assurance Coordinator who will be responsible for leading material inspections and partnering with cross functional groups to achieve the resolution of quality issues within the business. The Quality Assurance Coordinator will lead Receiving and Inspection activities to ensure that inbound material meets all mechanical, electrical, and cosmetic specifications as identified in the quality inspection plan. They will support Supplier Quality Engineering with investigations associated with the Nonconformance Report process and the Materials Review Board. They will also champion activities within Materials Management, Documentation Management, to meet and report related metrics.

Company Overview

FUJIFILM Sonosite, Inc. is the innovator and world leader in bedside and point-of-care ultrasound, and an industry leader in ultra-high frequency micro-ultrasound technology. Headquartered near Seattle, the company is represented by a global distribution network in over 100 countries. Sonosite’s portable, compact systems are expanding the use of ultrasound across the clinical spectrum by cost-effectively bringing high-performance ultrasound to the point of patient care. For more information, please visit www.sonosite.com .

FUJIFILM Corporation is a subsidiary of FUJIFILM Holdings Corporation. FUJIFILM Holdings Corporation, headquartered in Tokyo, leverages its depth of knowledge and proprietary core technologies to deliver innovative products and services across the globe through the four key business segments of healthcare, electronics, business innovation, and imaging with over 70,000 employees. Guided and united by our Group Purpose of “giving our world more smiles,” we address social challenges and create a positive impact on society through our products, services, and business operations. Under its medium-term management plan, VISION2030, which ends in FY2030, we aspire to continue our evolution into a company that creates value and smiles for various stakeholders as a collection of global leading businesses and achieve a global revenue of 4 trillion yen (29 billion USD at an exchange rate of 140 JPY/USD). For more information, please visit: www.fujifilmholdings.com .

For further details about our commitment to sustainability and Fujifilm’s Sustainable Value Plan 2030, click here .

Job Description

Essential Job Functions:

• Responsible for supporting and administering Nonconforming Reports by Ensuring that all reports are documented, investigated, and closed in a timely manner.
• Conduct thorough inspections and tests on incoming materials, in-process components, and finished medical devices to ensure they meet established quality specifications.
• Analyze and interpret inspection and testing data to identify trends, potential quality issues, and areas for improvement.
• Interface directly with internal and external customers and regulatory agencies as required.
• Identify and resolve product and engineering design issues by identifying short-term and long-range issues.
• Support Quality Metrics development and monitoring, participating in regular business and quality system performance reviews.
• Receive, document, and respond to complaints if Post Market team requires additional support. Monitor investigations and ensure timely follow-up of actions.
• Other duties as assigned.
  
  

Knowledge/Experience:

• 2 years in the medical device or highly regulated industry.
• 2 years inventory management and/or quality experience and understanding of regulatory agency (cGMP/ISO) requirements.
• Associate’s degree, preferably in engineering, biological sciences, or a clinical health care specialty.
• Knowledge of applicable regulations and standards, such as ISO 13485, FDA QSR, and other relevant guidelines.
• Six Sigma and/or Lean Sigma experience a bonus
  
  

Skills/Abilities:

• Enthusiastic self-starter with excellent verbal, written, presentation, negotiation, and interpersonal communication skills.
• Demonstrated organizational, problem solving, analytical, and computer skills, with a strong attention to detail.
• Working knowledge of & ability to use precision measurement equipment such as dial indicators, micrometers, calipers, height, and thread gages, etc.
• Working knowledge of engineering drawings and ANSI Standards.
• Experience with Oracle Business System or comparable electronic inventory management system.
• Demonstrated willingness to take initiative and become directly involved in planning, problem solving, and execution of work in a team environment.
• Ability to contribute to a positive and productive work environment at SonoSite through effective collaboration with cross-functional organizations.
  
  

Salary and Benefits:

• $30.00/hr - $35.00/hr depending on experience (Compensation will vary based on skills, experience and location; it is not typical to be hired at or above the top of the salary range).
• Insurance:
• Medical, Dental & Vision
• Life & Company paid Disability
• Retirement Plan (401k):
• 4% automatic Company contribution
• Fujifilm matches 50 cents for every dollar you contribute, up to 6% of your salary
• Paid Time Off:
• You can accrue up to three (3) weeks of PTO in your first year of employment
• PTO increases based on years of service
• Employee Choice Holidays:
• Four (4) additional paid days off, based on date of hire in the calendar year
• Paid Holidays:
• Eight (8) paid holidays per year
  

FUJIFILM Sonosite 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 .

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

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EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (ffss-hr@fujifilm.com or (425) 951-1200).