Overview

Senior Supplier Quality Engineer - Bothell, WA

FUJIFILM, Sonosite, Inc . We are an innovative and high performance culture with tremendous opportunities. People who work here are given the unique opportunity to contribute to the advancement of healthcare throughout the world. Headquartered in Bothell, WA USA, Fujifilm Sonosite is represented by a global distribution network in over 100 countries. Since its inception, Fujifilm Sonosite’s lightweight, robust products have created and led the point-of-care ultrasound market. From sophisticated urban hospital emergency rooms to clinics in austere, remote villages, Fujifilm Sonosite systems are used by over 21 medical specialties and provide clinicians around the world with a cost-effective tool for improving patient safety and workflow efficiency. Fujifilm Sonosite holds a number of prestigious design awards and has in excess of 145 patents.

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Job Summary:

The Senior Supplier Quality Engineer is responsible for implementing Purchasing Controls and Supplier Quality processes such as the purchase or acquisition of manufacturing materials, components, software, sub-assemblies, and contract manufactured finished devices/products or services, and their introduction into the Fujifilm supply chain, including quality of spare parts and third-party manufacturers (TPMs), Original Equipment Manufacturers (OEM’s). It is also to ensure compliance to regulatory requirements and/or procedures for regulated products/processes across the North America markets and our affiliates.

Essential Job Functions:

• Supports on-site/off-site supplier quality development including coordination / management of required internal/external resources.
• Enforces the annual definition of the quality improvement plan (QIP) based on business needs and timely implementation
• Manages the early involvement of suppliers in new product development and product/component improvement.
• Maintains and follows-up on the Supplier Quality Related KPI’s towards the supplier.
• Leads quality system audits. Coaches and manages the SQE team ensuring the competences and capabilities are in line with the business needs.
• Participates in the Supplier Selection process for the quality aspects, to ensure supplier quality
• Maintains and sets supplier quality aspects for new / improved products ensuring a.o. manufacturability aspects at suppliers
• Contribute to sourcing decisions identifying required supplier capability and quality level
• Identifies gaps between required and current supplier capabilities, and drives quality improvement plan / risk mitigation accordingly
• Creates, releases, and continuously drives the improvement of tools, equipment and manufacturing processes and related Quality systems to meet the product specifications.
• Identifies cost saving opportunities with the supplier
• Implements design and manufacturing process changes at supplier level

Knowledge and Experience:

• 5 years of experience
• BA or BS in engineering discipline required; A minimum of 5 years of direct experience in healthcare compliance and or Medical Device Manufacturing
• Experience working in the Product Development Lifecycle process
• Work with critical components or assemblies with our suppliers
• Experience auditing Suppliers to ISO 13485 Standard
• Experience driving process improvements with suppliers based on event and or data driven decisions

Skills and Abilities:

• Strong written and verbal communication skills
• Excellent knowledge and experience with software programs such as Microsoft Word, Excel, and PowerPoint
• Knowledge and experience with Lean Manufacturing Tools
• Strong organizational, process, and interpersonal skills
• Experience with project management in a matrix business organization
• The ability to facilitate clarity where ambiguity may exist in complex business situations
• Ability to lift 25lbs with or without accommodations

The company requires that the successful candidate hired for this position be fully vaccinated for Covid-19 absent being granted an accommodation due to medical, pregnancy, or sincerely held religious belief or other legally required exemption.

FUJIFILM Sonosite, Inc. 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.

FUJIFILM Sonosite, Inc. 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.

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 425-951-1200, or via e-mail at ffss-hr@fujifilm.com. 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.

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