Verathon ® is looking for a Senior Complaints Specialist/Coordinator to become the newest member of our Quality Assurance Team located in our Bothell, WA headquarters.
The Sr. Complaints Specialist/Coordinator coordinates activities related to Verathon Customer Complaint processes, Medical Device Reporting (MDR), Mandatory Problem Reporting (MPR), and Vigilance Reporting processes to assure continued compliance to global regulatory requirements. This role is also responsible for compiling and analyzing post market surveillance data for potential corrective action and continued improvement.
Essential duties and responsibilities
Coordinates complaint intake, evaluation, and investigation activities
Assesses potentially critical complaints (PCC) for Medical Device Reporting (MDR), Mandatory Problem Report (MPR), and Vigilance reporting requirements
Prepares and submits MDR / Vigilance reports to US and global agencies as required
Authorizes closure of potentially critical complaints
Escalates issues that may require corrective action
Generates quality data for product quality trending and improvement opportunity
Management of complaint, Medical Device and Vigilance Reporting Files
Provides training / certifications for complaint intake and returned device evaluation
Interacts with Customer Care to support complaint data intake requirements and complainant follow-up
Knowledge, Skills, and Abilities necessary to perform essential functions
Strong English verbal and written communication skills
Demonstrate strong critical thinking skills to evaluate and investigate customer complaints, determining the need for CAPA and MDR
Demonstrate excellent people skills including ability to probe with questions for information
Knowledge of complaint handling and reporting requirements as defined within the following:
21 CFR Part 803 (US)
21 CFR Part 820 (US)
MEDDEV 2 12-1 (EU)
MHLW Ministerial Ordinance No. 169 (Canada)
Article 64-5-2 of the Japanese Enforcement Regulations (Japan)
Section 41FN(3)(d) of the Therapeutic Goods Act 1989 complaint handling and reporting requirements (Australia)
Demonstrate knowledge in a manner that helps others know how to comply with requirements - assist mode
Show willingness and ability to learn new processes and suggest options for compliance and efficiency
Excellent Analytical skills and ability to synthesize trending data into meaningful information for the organization
Demonstrated leadership; attention to detail and ability to solve problems and communicate issues; ability to work on multiple projects
Learn and implement company policies, procedures and work instructions
Minimum Education and Experience Requirements
Education - Bachelor Degree in a scientific discipline, nursing or medical technician preferred
3+ Years' experience in Medical Device/Pharma Industry with experience in QSR, Complaint Mgmt, Medical Device or Healthcare
Verathon is a wholly owned subsidiary of Roper Industries, an acquisitive S&P 500 and NYSE listed diversified growth company. Verathon is headquartered in the greater Seattle area, in Bothell, Washington, and has 7 international subsidiaries in Canada, Europe and Asia. The company designs, manufactures, distributes and markets reliable, state-of-the-art medical devices and services to the health care community that offer meaningful improvement in patient care. Our largest brands, BladderScan and GlideScope, have achieved worldwide recognition as the number one leader in their respective markets. Verathon is a financially sound company with consistent growth and performance even during down market cycles. We have a strong pipeline of new products for multiple areas of discipline within the heath care industry.
Verathon was acquired by Roper Industries (US Ticker symbol ROP) in December 2009 as a platform for future acquisitions leveraging the talented management team and extraordinary channel development in developed country markets.
Verathon offers competitive compensation and a complete benefits package to full-time employees including company sponsored health plan, 401k with match, wellness and tuition reimbursement and the advantages of an environment that supports your development and recognizes your achievements.
Verathon is an equal opportunity employer and strongly supports diversity in the workplace. We believe that diverse ideas, opinions and perspectives will build a strong foundation for success.
Verathon - 8 months ago