Post-Market Surveillance SpecialistFUJIFILM SonoSite, Inc
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.
The Post-Market Surveillance Specialist will support Quality activities associated with complaint handling and MDR/Vigilance submission. Also includes supporting activities with:
- Non-Conformance Investigations
- CAPA processes
- Field Actions
- Documentation Management
- Quality Metrics
Essential Job Functions:
- Responsible for processing complaints and incident (MDR, Vigilance) reports to ensure that complaints are documented, reviewed, evaluated, investigated, and formally closed in a timely manner. Interfaces directly with internal and external customers and regulatory agencies as required.
- Support quality metrics development and monitoring, participating in regular business and quality system performance reviews.
- Support the administration of the CAPA system, working with other areas of the organization to ensure processes are following and timely closure of open CAPA files.
- Supportive role in carrying out the requirements of the company's quality system.
- Abide by corporate code of conduct and other applicable policies, procedures and work instructions
- Other duties as assigned.
Knowledge and Experience:
- 2+ years in the medical device or biotechnology industry, with hands-on, in-depth knowledge and understanding of regulatory agency (cGMP/ISO) requirements for complaint management.
- Associate Degree (or equivalent experience), preferably in engineering, biological sciences or a clinical health care specialty.
- Strong familiarity with 21 CFR 820, 803, 806 regulations and the ISO 13485, or ISO 9001 standard.
Skills and Abilities:
- Enthusiastic self-starter with excellent verbal, written, presentation, negotiation, and interpersonal communication skills. Able to professionally represent the company to medical professionals, regulators, and customers.
- Demonstrated organizational, problem solving, analytical, and computer skills, with a strong attention to detail.
- Flexible and able to manage and prioritize multiple projects in a fast-paced environment.
- Demonstrated willingness to take initiative and become directly involved in planning, problem solving, and execution of work in a team environment.
- Highly motivated. Interest in expanding knowledge and growth within the organization.
- Ability to contribute to a positive and productive work environment at SonoSite through effective collaboration with cross functional organizations.
- Ability to lift 25lbs without accommodations
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/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 firstname.lastname@example.org . 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.