- Innovative thinker, knowledgeable and intensely committed to ensure that products we supply conform to the FDA Quality System Regulation and ISO
- 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.
- 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.
- 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.
- $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
-
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Quality Engineer III - Bothell, United States - FUJIFILM Corporation
Description
Overview:
Quality Engineer III - Bothell, WA
FUJIFILM Sonosite, Inc. -- If you are looking for work that matters, youll 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.
External US: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:
Knowledge and Experience:
Skills and Abilities:
Salary and Benefits:
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
Equal Employment Opportunity Employer
FUJIFILM Sonosite is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age, protected veteran status, disability status, or any other characteristic protected by law.
Americans with Disabilities Act
In compliance with the ADA Amendments Act, should you have a disability that requires assistance and / or reasonable accommodation with the job application process, please contact the Human Resources department via phone at , or via e-mail at ffss- Additionally, the affirmative program/plan is available for review upon formal request by employees and applicants for employment in the Human Resources office during regular office hours.
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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