Manager, Quality

Manager, Quality - 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.

Job Summary:

Essential Job Functions:

• Manage the Quality Assurance group, providing direction and leadership, ensuring that company objectives and quality system requirements are met.
• Enhance, implement and monitor the quality management system to ensure high product quality and customer satisfaction while maintaining regulatory compliance.
• Manage 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 ISO9001, ISO 13485, 21 CFR 820.
• Ensure continued compliance with global QMS requirements under the MDSAP program.
• Oversee CAPA 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.
• Oversee and support product complaint trending, investigations and medical device reporting/vigilance.
• Manage all field actions and associated recall activities when necessary.
• Support the Product Development Process and ensure appropriate practices and scientific analyses are employed. Ensure quality representation on development projects.
• Provide resources and support to other functions of the Quality team as needed.
• Ensure information relating to product quality and the quality system is communicated to senior management.

Knowledge and Experience:

• Bachelor’s Degree in Engineering, Business, Mathematics, Life Science, or technical field with emphasis on statistical skills. Advanced degree or certifications preferred.
• Minimum 3 years Quality Management System experience within the medical device industry (ISO 9001, ISO13485); other regulated industries may be considered
• Demonstrated ability to lead and influence multi-discipline teams to achieve goals
• Required: FDA 21 CFR 820 / ISO13485:2003 / cGMP knowledge base
• Required: Quality lead auditor certification
• Required: Experience in electromechanical medical device manufacturing facilities
• Preferred: Experience with Oracle’s Agile PLM software
• Preferred: ASQ Certified Quality Engineer (CQE) or other quality certification
• Preferred: Operational Excellence/Six Sigma/Lean training or certifications

Skills and Abilities:

• Excellent interpersonal and communication skills
• Excellent attention to detail
• Ability to work on one’s own initiative
• 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
• Ability to travel (domestic and international) ~5-10%
• 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 belif 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 https://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.