Amerit Consulting
Sr. Medical Device Complaint Specialist
Amerit Consulting - San Diego, California, United States, 92189
Work at Amerit Consulting
Overview
- View job
Overview
2 days ago Be among the first 25 applicants
Get AI-powered advice on this job and more exclusive features.
Direct message the job poster from Amerit Consulting
Our client, a US Fortune 250 company and a global medical technology corporation serving customers in Clinical Labs, Health care research & Pharmaceutical industry, seeks an accomplished
Sr. Medical Device Complaint Specialist. Job Title: Sr. Medical Device Complaint Specialist Contract Type: 12 Months + Overview: The Sr. Complaint Specialist Customer Advocacy 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, assists in timely regulatory reporting (US MDR and Canada MDPR), and resolving issues. Additionally, it provides technical expertise/troubleshooting for internal and external customers when requested. Key Responsibilities: Conduct product complaint investigations and write failure investigation reports Ensure accuracy for complaint file documentation and regulatory reporting decision activities. Ensure timely follow-up with customers and company representatives for reported issues. Ensure complaint files are accurate and complete and in line with good documentation practices. Assists regulatory reporting activities to ensure medical device reports are submitted within FDA and Health Canada timeframes and company policy. Demonstrate sound independent decision making in regard to medical device reporting 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 and/or department RNs to assess the severity of complaints and understand the typical clinical use to provide input to the technical investigation for optimal root cause resolution as needed. In concert with the department supervisor and/or manager and escalation teams, strategize to direct the efforts to ensure infusion customer satisfaction. Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Required Qualifications: Education : Bachelors degree in related field is desirable 5+ years of medical device experience is desired, preferably in a regulatory or technical complaint investigation capacity. Knowledge of the use of infusion pumps and disposable tubing equipment is desired but not necessary. 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. 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 read, analyze, and interpret common scientific and technical journals, and legal documents. 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 clinical and technical skills to regulatory functions. Provide support for internal quality audits of complaint files / MDR documentation, as well as external audits/inspections from Regulatory Bodies as requested. I'd love to talk to you if you think this position is right up your alley, and assure prompt communication, whichever direction. If you are looking for rewarding employment and a company that puts its employees first, we'd like to work with you. Title: Lead Recruiter Company Overview: Amerit Consulting
is an extremely fast-growing staffing and consulting firm. Amerit Consulting was founded in 2002 to provide consulting, temporary staffing, direct hire, and payrolling services to Fortune 500 companies nationally: as well as small to mid-sized organizations on a local & regional level. Currently, Amerit has over 2,000 employees in 47 states. We develop and implement solutions that help our clients operate more efficiently, deliver greater customer satisfaction, and see a positive impact on their bottom line. We create value by bringing together the right people to achieve results. Our clients and employees say they choose to work with Amerit because of how we work with them - with a service that exceeds their expectations and a personal commitment to their success. Our deep expertise in human capital management has fueled our expansion into direct hire placements, temporary staffing, contract placements, and additional staffing and consulting services that propel our clients businesses forward. Amerit Consulting provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. Applicants with criminal histories are considered in a manner that is consistent with local, state and federal laws. Seniority level
Seniority level
Mid-Senior level Employment type
Employment type
Contract Job function
Job function
Quality Assurance Industries
Medical Equipment Manufacturing Referrals increase your chances of interviewing at Amerit Consulting by 2x Get notified about new Device Specialist jobs in
San Diego, CA . EHS Specialist I (Must Have Manufacturing/Warehouse EHS Experience) Urgent Need - Onsite
Customer Complaints Specialist (Must Have Trackwise, Complaint Investigations, Trending)
EHS Specialist I - Required Exp in EHS Warehouse/Manufacturing (Onsite) Urgent Need
Operations Specialist I (Must Have Pipetting Exp)
Quality Complaints Management Specialist - Urgent Need
Manager, Medical Affairs T2D and Data Products Franchise (Hybrid)
Market Surveillance Specialist (Must Have Complaints & Medical Device Exp)
Quality Complaints Management Specialist - Urgent Need
Clinical Operations Specialist I (Must Have Pipetting Exp) - Entry Level
Marketing Specialist - Exp in Medical Device Industry and Infusion Systems)
Operations Specialist I (Must Have pipetting Exp) - Bachelors degree in Chemistry or Biology
Customer Complaints Specialist (Must Trackwise, Complaints Investigations & Trending)
Operations Specialist II (Lab Exp is Required)
EHS Specialist I - Required Warehouse / Manufacturing EH&S background (Urgent Need) Onsite
Research Reagent Development Data Specialist
Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr
Sr. Medical Device Complaint Specialist. Job Title: Sr. Medical Device Complaint Specialist Contract Type: 12 Months + Overview: The Sr. Complaint Specialist Customer Advocacy 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, assists in timely regulatory reporting (US MDR and Canada MDPR), and resolving issues. Additionally, it provides technical expertise/troubleshooting for internal and external customers when requested. Key Responsibilities: Conduct product complaint investigations and write failure investigation reports Ensure accuracy for complaint file documentation and regulatory reporting decision activities. Ensure timely follow-up with customers and company representatives for reported issues. Ensure complaint files are accurate and complete and in line with good documentation practices. Assists regulatory reporting activities to ensure medical device reports are submitted within FDA and Health Canada timeframes and company policy. Demonstrate sound independent decision making in regard to medical device reporting 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 and/or department RNs to assess the severity of complaints and understand the typical clinical use to provide input to the technical investigation for optimal root cause resolution as needed. In concert with the department supervisor and/or manager and escalation teams, strategize to direct the efforts to ensure infusion customer satisfaction. Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Required Qualifications: Education : Bachelors degree in related field is desirable 5+ years of medical device experience is desired, preferably in a regulatory or technical complaint investigation capacity. Knowledge of the use of infusion pumps and disposable tubing equipment is desired but not necessary. 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. 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 read, analyze, and interpret common scientific and technical journals, and legal documents. 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 clinical and technical skills to regulatory functions. Provide support for internal quality audits of complaint files / MDR documentation, as well as external audits/inspections from Regulatory Bodies as requested. I'd love to talk to you if you think this position is right up your alley, and assure prompt communication, whichever direction. If you are looking for rewarding employment and a company that puts its employees first, we'd like to work with you. Title: Lead Recruiter Company Overview: Amerit Consulting
is an extremely fast-growing staffing and consulting firm. Amerit Consulting was founded in 2002 to provide consulting, temporary staffing, direct hire, and payrolling services to Fortune 500 companies nationally: as well as small to mid-sized organizations on a local & regional level. Currently, Amerit has over 2,000 employees in 47 states. We develop and implement solutions that help our clients operate more efficiently, deliver greater customer satisfaction, and see a positive impact on their bottom line. We create value by bringing together the right people to achieve results. Our clients and employees say they choose to work with Amerit because of how we work with them - with a service that exceeds their expectations and a personal commitment to their success. Our deep expertise in human capital management has fueled our expansion into direct hire placements, temporary staffing, contract placements, and additional staffing and consulting services that propel our clients businesses forward. Amerit Consulting provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. Applicants with criminal histories are considered in a manner that is consistent with local, state and federal laws. Seniority level
Seniority level
Mid-Senior level Employment type
Employment type
Contract Job function
Job function
Quality Assurance Industries
Medical Equipment Manufacturing Referrals increase your chances of interviewing at Amerit Consulting by 2x Get notified about new Device Specialist jobs in
San Diego, CA . EHS Specialist I (Must Have Manufacturing/Warehouse EHS Experience) Urgent Need - Onsite
Customer Complaints Specialist (Must Have Trackwise, Complaint Investigations, Trending)
EHS Specialist I - Required Exp in EHS Warehouse/Manufacturing (Onsite) Urgent Need
Operations Specialist I (Must Have Pipetting Exp)
Quality Complaints Management Specialist - Urgent Need
Manager, Medical Affairs T2D and Data Products Franchise (Hybrid)
Market Surveillance Specialist (Must Have Complaints & Medical Device Exp)
Quality Complaints Management Specialist - Urgent Need
Clinical Operations Specialist I (Must Have Pipetting Exp) - Entry Level
Marketing Specialist - Exp in Medical Device Industry and Infusion Systems)
Operations Specialist I (Must Have pipetting Exp) - Bachelors degree in Chemistry or Biology
Customer Complaints Specialist (Must Trackwise, Complaints Investigations & Trending)
Operations Specialist II (Lab Exp is Required)
EHS Specialist I - Required Warehouse / Manufacturing EH&S background (Urgent Need) Onsite
Research Reagent Development Data Specialist
Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr