Quality Engineer III

Overview

Quality Engineer III - Bothell, WA

 

FUJIFILM Sonosite, Inc. -- If you are looking for work that matters, you’ll find it at FUJIFILM Sonosite.  As the creator of point of care ultrasound, we dedicate every day to the innovation and development of imaging solutions that enable clinicians to provide improved healthcare in leading institutions, underserved populations and communities in crisis around the globe.  At FUJIFILM Sonosite, we are in the relentless pursuit of answers that allow our customers to be confident that they are making the best clinical decisions for any patient, anywhere, anytime.  Members of the FUJIFILM Sonosite team embody our company values: Go boldly, Stay curious, Passion fuels us, Respect each other, Own it and Act with integrity. Headquartered in Bothell, WA USA, FUJIFILM Sonosite is the proud recipient of numerous prestigious design awards and has in excess of 145 patents.  Our point of care ultrasound systems are sold in more than 100 countries.

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Summary:

 

The Quality Engineer III is responsible for taking the lead 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 III will be responsible for driving activity around process validation, as well as participating in establishing and monitoring systems related to Inspection, Training, Supplier Qualification, New Product Introduction, Complaints, and Corrective/Preventative Action. 

 

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.
• Takes lead of implementing standard approaches to problem solving and
• prevention. Devises creative approaches to solving problems encountered.
• Take lead on new product development in ensuring compliance with Quality System requirements.
• 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.
• Oversee Risk Management activities including Failure Mode and EffectsAnalysis.
• Lead the MRB process for discrepant material investigations and decisions.
• Support supplier qualification and monitoring.
• Review complex complaints and complaint trends and participate in failure investigations.
• Support development and continuous improvement of quality system procedures.
• Report to management on quality issues and trends.
• Available to be on calls in the morning or evening with global contract manufacturers and suppliers in other time zones.

Knowledge and Experience:

• BS in Mechanical/Electrical/Industrial Engineering or equivalent experience required.
• At least 4-7 years of experience working within a Medical Device Manufacturer.
• 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.).
• Experience with AQLs, product inspections, vendor qualifications and audits.

Skills and Abilities:

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

Salary and Benefits:

• $78,0000 - $110,000 depending on experience + variable pay opportunity
• 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 compensatio