ALOIS Solutions
PostMarket Survaillance Specialist Complaint Specialist
ALOIS Solutions, San Diego, California, United States, 92189
Job Description
Job Description
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.
Company Description
It is one of the largest companies in its field, manufacturing and selling medical devices, instrument systems, and diagnostic products globally. Its mission is to advance the world of health by improving medical discovery, diagnostics, and the delivery of care.
Company Description It is one of the largest companies in its field, manufacturing and selling medical devices, instrument systems, and diagnostic products globally. Its mission is to advance the world of health by improving medical discovery, diagnostics, and the delivery of care.
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.
Company Description
It is one of the largest companies in its field, manufacturing and selling medical devices, instrument systems, and diagnostic products globally. Its mission is to advance the world of health by improving medical discovery, diagnostics, and the delivery of care.
Company Description It is one of the largest companies in its field, manufacturing and selling medical devices, instrument systems, and diagnostic products globally. Its mission is to advance the world of health by improving medical discovery, diagnostics, and the delivery of care.