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. 

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.

Essential Job Functions: 

• Innovative thinker, knowledgeable and intensely committed to ensure that products we supply conform to the FDA Quality System Regulation and ISO 13485.
• Understands and can implement standard approaches to problem solving and prevention.
• Participate in Configuration Management initiatives.
• Support new product development in ensuring compliance with Quality System requirements.
• Review/approve engineering changes on behalf of QA.
• Participate in Corrective and Preventative activities.
• 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.
• Lead Quality related projects and Host Review Meetings.
• Report to management on quality issues and trends.

Knowledge/Experience:

• BS or MS degree in Mechanical/Electrical/Industrial Engineering.
• At least 1-3 years of experience working within the Quality organization of a Medical Device Manufacturer, Aerospace, Pharma, or other highly regulated industry.
• Applications of Lean principles such as Value Stream Mapping, Standard Work, 5S, Kaizen.
• 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/Abilities:

• Ability to travel 10% domestically and internationally as needed.
• 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.

Salary and Benefits:

• $90,000.00 - $110,000.00/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).