Post-Market Surveillance Specialist - Bothell, WA Relevant Educational Qualifications Job1 month ago - Graphics Design / Video Editing / Animation - Bothell - 108 views
The Post Market Surveillance Specialist position is accountable for individual work projects as well as training and documentation. The Post Market Surveillance Specialist may also review and monitor data and document quality, as requested by the manager. This position will provide support in preparation of data analysis, reporting, trending, and documentation review, coordination of complaint and lot qualification data, device history reviews and review and closure of certain categories of complaints. It also requires some regulatory assessment capability along with MDR/Vigilance reporting. This role requires substantial interaction across functional organizations including Regulatory Affairs, Quality Assurance, R&D, Clinical, Operations.
Essential Job Functions:
- Track all stages of the Complaint Documentation process including: Data Analysis, Reporting and Trending, Documentation Review, Coordination of complaint and lot qualification data, Device history reviews, Review and closure of certain categories of complaints.
- Maintain accurate documentation and files related to special projects, complaints and lot Qualification.
- 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
- Review and analyze lot documentation (DHR's) to determine if there are any anomalies that may have related to reported product failures.
- Support database development and reporting capabilities related to the complaint / reliability department needs.
- Assist during FDA, ISO or other third party or internal audits.
- Train others on the requirements of the Complaint Coordinating activities, including follow-up with the Customer Care Group.
- Support review and investigation of adverse events
- Post market surveillance reporting (MDRs, MDVs, MDPRs, etc.).
- Perform basic product review and failure analysis.
- Abide by corporate code of conduct and other applicable policies, procedures and work instructions
- Other duties as assigned
Knowledge and Experience:
- 2-4 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.