FUJIFILM SonoSite is seeking a Quality Manager to oversee multiple groups under the quality umbrella, headquartered in Bothell, WA. This position is responsible for enhancing and maintaining quality assurance programs, policies, processes, and controls within the global Quality Management System. This position will also work with Regulatory management and cross-functional teams to drive systems/process improvement activities for regulatory compliance and business efficiencies; partnering with manufacturing and operations, customer relations, new product development, and other areas as assigned.

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

Essential Job Functions:

• Responsible for the Quality Assurance group, providing direction and leadership, ensuring that company objectives and quality system requirements are met.
• Enhance, implement and monitor quality management system changes to ensure high product quality and customer satisfaction while maintaining regulatory compliance.
• Responsible for the existing Receiving Inspection (RI) team as well as drive continuous improvement activities within the department.
• Support the Operations team identifying new, or changes to existing, processes and systems to improve the overall effectiveness, efficiency and compliance of the quality system in accordance with the standards and regulations such as ISO 13485 and 21 CFR 820.
• Ensure continued compliance with global QMS requirements under the MDSAP program.
• Oversee the global CAPA program and ensure that the established quality system processes for corrective and preventive actions are maintained and followed throughout the company.
• Produce, track and trend quality metrics to deliver tangible improvements to the overall business.
• Manage and support product complaint processing, trending, investigations and medical device reporting/vigilance to all required competent authorities.
• Responsible for all field actions and associated recall activities when necessary.
• Support the Product Development Process and ensure appropriate practices and scientific analyses are employed. Ensure support of quality representation on development projects.
• Responsible for leading the Configuration Management and Document Control Team.
• Provide resources and support to other functions of the Quality organization as needed.
• Ensure information relating to product quality and the quality system is communicated to senior management on a regular basis. 

Knowledge and Experience:

• Minimum 6-8 years Quality Management System experience within the medical device industry (ISO 9001, ISO13485, 21 CFR 820); other regulated industries may be considered
• Demonstrated ability to lead and influence multi-discipline teams to achieve goals
• Excellent interpersonal and communication skills
• Excellent attention to detail
• Experience with Internal and External Audits
• Strong analytical and problem-solving skills
• Demonstrate sound risk-based judgment/rationale
• Good report writing and reviewing skills
• Ability to prioritize the workload and effective time management in a fast-paced environment
• Bachelor’s degree in Engineering, Business, Mathematics, Life Science, or technical field with emphasis on statistical skills.  Advanced degree or certifications preferred.
• Ability to travel (domestic and international) ~10%

Skills and Abilities:

• Required: FDA 21 CFR 820 / ISO13485:2016 / cGMP knowledge base
• Required: Experience in electromechanical medical device manufacturing facilities
• Required: Experience in managing a Team
• Preferred: Operational Excellence/Six Sigma/Lean training or certifications
• Preferred: Project Management Experience
• Preferred: Quality lead auditor certification

Salary and Benefits:

• $105,000.00/yr - $135,000.00/yr 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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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.

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).