Complaint Mgmt specialist 3

Pyramid Consulting, Inc; San Diego (CA); On-site; USD 55,104 - 63,369; Full time

Benefits offered by this job

Health insurance (medical, dental, vision)

401(k) plan

Paid sick leave

Job summary

A leading consulting firm in healthcare is seeking a Complaint Management Specialist for a contract opportunity in San Diego, CA. The role involves conducting product complaint investigations, ensuring compliance with documentation standards, and decision-making regarding complaint handling. Ideal candidates should have a Bachelor's degree and 3-5 years of experience in the medical device industry. This position is essential for regulatory compliance and customer satisfaction. Employee benefits include health insurance and a 401(k) plan.

Qualifications

• 3-5 years of medical device experience preferred, especially in regulatory or technical complaint investigation.
• 2 years of experience with medical device complaint handling or similar regulated environment.
• Working knowledge of QA, Regulatory/Quality Compliance in medical device industry preferred.

Responsibilities

• Conduct product complaint investigations and write reports.
• Ensure documentation accuracy and regulatory compliance.
• Demonstrate sound independent decision making in complaint handling.
• Collaborate with management to assess complaint severity.
• Comply with FDA regulations and company policies.
• Ensure timely follow-up with internal customers.

Skills

Complaint Handling/ Investigation

PCB/ Board Circuit

Knowledge of electronics

Education

Bachelor’s degree in related field

Job description

Pay Range

$40.00/hr - $46.00/hr

Base Pay Range

$40.00/hr - $46.00/hr

Immediate need for a talented Complaint Mgmt Specialist 3, This is a 03 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 Diva ID: 25-95196

Pay Range: $40 - $46 /hour. Employee benefits include, but are not limited to, 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 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.

Key Requirements and Technology Experience

• Key Skills; Complaint Handling/ Investigation, PCB/ Board Circuit
• 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.

Job Details

• Senior level: Not Applicable
• Employment type: Contract
• Job function: Information Technology
• Industries: Medical Equipment Manufacturing

Pyramid 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, colour, 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.