LanceSoft
Sr. Complaint Specialists, Designated Complaint Handling Unit (DCHU)
Job Description Summary
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.
Duties & 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. • Provide or facilitate clinical expertise/troubleshooting for customers as appropriate. • 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.
Qualifications:
Education & Experience • 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,
Knowledge, Skills & Abilities • Critical thinking skills. • Ability to solve problems and to meet multiple deadlines within a fast-paced environment. • Excellent writing skills, knowledgeable of good documentation practices. • Ability to work on multiple projects with various disciplines. • Ability to adapt quickly in an ever-changing environment • Ability to work in a complaint investigation laboratory environment containing hazardous materials • Able to utilize computers for development of reports and summary of project experience including word processing and spreadsheet computer applications such as Microsoft Word, PowerPoint and Excel. • Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. • Ability to effectively present information to management, ancillary departments, and/or customers. • Ability to apply technical skills to regulatory functions. • Provide support for internal quality audits of complaint files, as well as external audits/inspections from Regulatory Bodies as requested.
Flexibility and excellent organizational skills to manage/adapt to competing priorities and volume of tasks.
Note: Job requires flexible schedule. Training will be on 1st shift 8Am to 5PM in San Diego. For 5-6 months in San Diego, 11-7pm, then once job moves to Otay it will be first shift.
Job Description Summary
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.
Duties & 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. • Provide or facilitate clinical expertise/troubleshooting for customers as appropriate. • 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.
Qualifications:
Education & Experience • 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,
Knowledge, Skills & Abilities • Critical thinking skills. • Ability to solve problems and to meet multiple deadlines within a fast-paced environment. • Excellent writing skills, knowledgeable of good documentation practices. • Ability to work on multiple projects with various disciplines. • Ability to adapt quickly in an ever-changing environment • Ability to work in a complaint investigation laboratory environment containing hazardous materials • Able to utilize computers for development of reports and summary of project experience including word processing and spreadsheet computer applications such as Microsoft Word, PowerPoint and Excel. • Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. • Ability to effectively present information to management, ancillary departments, and/or customers. • Ability to apply technical skills to regulatory functions. • Provide support for internal quality audits of complaint files, as well as external audits/inspections from Regulatory Bodies as requested.
Flexibility and excellent organizational skills to manage/adapt to competing priorities and volume of tasks.
Note: Job requires flexible schedule. Training will be on 1st shift 8Am to 5PM in San Diego. For 5-6 months in San Diego, 11-7pm, then once job moves to Otay it will be first shift.