Pyramid Consulting, Inc
Complaint Mgmt specialist 3
Pyramid Consulting, Inc, San Diego, California, United States, 92189
Immediate need for a talented Complaint Mgmt specialist 3. This is a 3 Months Contract opportunity with long-term potential and is located in San Diego, CA (Onsite). Please review the job description below and contact me ASAP if you are interested.
Job ID: 25-95814
Pay Range: $45 - $50/hour.
Employee benefits include health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
Key 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 reporting and other functions relating to the investigation of product complaints.
Provide or facilitate expertise/troubleshooting for customers as appropriate.
Collaborate with technical team or 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.
In concert with the department supervisor and/or manager and escalation teams, strategize to direct the efforts to ensure 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 customers and company representatives for reported issues.
Key Requirements and Technology Experience
Skills: Board Circuit/PCB/medical device or electrical equipment, infusion pump or disposable tubing.
Critical thinking skills.
Ability to solve problems and 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.
Running reports and summaries using Microsoft Word, PowerPoint, Excel.
Read, analyze, and interpret common scientific and technical journals and legal documents.
Respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
Effectively present information to management, ancillary departments, and/or customers.
Apply clinical and technical skills to regulatory functions.
Support internal quality audits of complaint files / MDR documentation and external audits/inspections from regulatory bodies as requested.
Bachelor’s degree in related field desirable.
3 years of medical device experience preferred, preferably in a regulatory or technical complaint investigation capacity.
2 years of experience with medical device complaint handling / post‑market surveillance or similar regulated environment preferred.
Working knowledge of QA, regulatory/quality compliance in a medical device industry preferred.
Knowledge of electronics preferred.
Our client is a leading Healthcare Industry and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.
PI Consulting, Inc. 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.
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Job ID: 25-95814
Pay Range: $45 - $50/hour.
Employee benefits include health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
Key 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 reporting and other functions relating to the investigation of product complaints.
Provide or facilitate expertise/troubleshooting for customers as appropriate.
Collaborate with technical team or 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.
In concert with the department supervisor and/or manager and escalation teams, strategize to direct the efforts to ensure 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 customers and company representatives for reported issues.
Key Requirements and Technology Experience
Skills: Board Circuit/PCB/medical device or electrical equipment, infusion pump or disposable tubing.
Critical thinking skills.
Ability to solve problems and 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.
Running reports and summaries using Microsoft Word, PowerPoint, Excel.
Read, analyze, and interpret common scientific and technical journals and legal documents.
Respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
Effectively present information to management, ancillary departments, and/or customers.
Apply clinical and technical skills to regulatory functions.
Support internal quality audits of complaint files / MDR documentation and external audits/inspections from regulatory bodies as requested.
Bachelor’s degree in related field desirable.
3 years of medical device experience preferred, preferably in a regulatory or technical complaint investigation capacity.
2 years of experience with medical device complaint handling / post‑market surveillance or similar regulated environment preferred.
Working knowledge of QA, regulatory/quality compliance in a medical device industry preferred.
Knowledge of electronics preferred.
Our client is a leading Healthcare Industry and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.
PI Consulting, Inc. 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.
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