Quality Assurance Coordinator

We are seeking a 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

At FUJIFILM Sonosite, we reinvent how healthcare is delivered with point-of-care ultrasound technology. As the leader in bedside ultrasound systems, our innovations save lives—from premature babies in NICUs to trauma patients in emergency rooms.

We’re looking for purpose-driven team members ready to build technology that impacts real-world scenarios, including natural disasters and even war zones. By joining FUJIFILM Sonosite, you’ll be part of a team that thrives on collaboration, out-of-the-box thinking, and a passion for life-saving innovations. Let’s make a difference together.

Our headquarters in Bothell, Washington, blends riverside charm with urban amenities, quality schools, and an ever-evolving downtown—all part of the vibrant Seattle metro area.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

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 and Experience:

• 2 years in the medical device or biotechnology industry.
• 2 years inventory management and/or quality experience and understanding of regulatory agency (cGMP/ISO) requirements.
• Associates Degree, preferably in engineering, biological sciences, or a clinical health care specialty or a combination of work history and education..
• 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 and Abilities:

• Enthusiastic self-starter with excellent verbal, written, presentation, negotiation, and interpersonal communication skills. Able to professionally represent the company to medical professionals, regulators, and customers.
• Demonstrated organizational, problem solving, analytical, and computer skills, with a strong attention to detail.
• Flexible and able to manage and prioritize multiple projects in a fast-paced environment.
• Demonstrated willingness to take initiative and become directly involved in planning, problem solving, and execution of work in a team environment.
• Highly motivated. Interest in expanding knowledge and growth within the organization.
• Ability to contribute to a positive and productive work environment at Sonosite through effective collaboration with cross functional organizations.
  
  

Salary and Benefits:

• $26.92/hr. - $31.25/hr. depending on experience
• 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).