MillenniumSoft Inc · 1 month ago
Sr. Complaint Specialist Investigation Lab - Onsite
San Diego, CA
Full-time
Onsite
Mid, Senior Level
3+ years expMillenniumSoft Inc is a company specializing in medical devices, and they are seeking a Senior Complaint Specialist Investigation Lab. The role is responsible for medical device post-market surveillance and complaint handling functions, including investigation of failed products and writing failure investigation reports.
Staffing & Recruiting
No H1B
Responsibilities
Conduct product complaint investigations and write failure investigation reports
Ensure accuracy for complaint file documentation and regulatory reporting decision activities
Ensure complaint files are accurate and complete and in line with good documentation practices
Demonstrate sound independent decision making in regard to medical device complaint handling and other functions relating to the investigation of product complaints. Asks questions of team leaders / management as needed
Collaborate with supervisor, manager to assess the severity of complaints and understand the typical use to provide input to the Technical investigation for optimal root cause resolution as needed
Handle product for investigation per quality system requirements
In concert with the department supervisor and/or manager and escalation teams, strategize to direct the efforts to ensure Dispensing customer satisfaction
Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments
Ensure timely follow-up with internal customers and company representatives for reported issues
Qualification
Required
The Sr. Complaint Specialist Investigation Lab role is responsible for medical device post-market surveillance as it relates to complaint handling functions
The role is responsible for the completion of all tasks associated with complaint handling including: investigation of failed product, working with hazardous materials in controlled lab environment, writing clear and effective failure investigation reports, review of reported events in the complaints database for trending and optimal root cause identification, handling and properly dispositioning parts for investigation, and resolving issues
Additionally, provides technical expertise/troubleshooting for internal and external customers when requested
Conduct product complaint investigations and write failure investigation reports
Ensure accuracy for complaint file documentation and regulatory reporting decision activities
Ensure complaint files are accurate and complete and in line with good documentation practices
Demonstrate sound independent decision making in regard to medical device complaint handling and other functions relating to the investigation of product complaints. Asks questions of team leaders / management as needed
Collaborate with supervisor, manager to assess the severity of complaints and understand the typical use to provide input to the Technical investigation for optimal root cause resolution as needed
Handle product for investigation per quality system requirements
In concert with the department supervisor and/or manager and escalation teams, strategize to direct the efforts to ensure Dispensing customer satisfaction
Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments
Ensure timely follow-up with internal customers and company representatives for reported issues
Preferred
Bachelor's degree in related field is desirable
3-5 years of medical device experience is desired, preferably in a regulatory or technical complaint investigation capacity
2+ years of experience with medical device complaint handling / post-market surveillance / medical device regulations or experience in a similar regulated environment preferred
Working knowledge of QA, Regulatory/Quality Compliance in a medical device industry preferred
Knowledge of electronics is preferred
Company
MillenniumSoft Inc
Hire us to hire for you Staffing is not a straightforward activity.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Sailaja Mashetty
Partner - Customer Sucess
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