Amick Brown is seeking an experienced Product Complaint Associate for our direct client.
Location: Santa Clara, CA
Duration: 1 year with Possible Extension
Primary Function of Position
The Regulatory Post Market Surveillance Coordinator investigates customer complaints, makes an initial reporting decision, and ensures completeness and consistency of complaints and related documentation.
Roles and Responsibilities
- Investigating complaints daily
- Complete RPMS new hire training and ongoing Regulatory Post Market Surveillance training as required.
- Follow and comply with company procedures and processes relating to complaint intake, assessment, and reporting.
- Process, record, and close assigned complaint handling activities promptly.
- Perform the preliminary classification of complaints.
- Perform Failure Analysis investigation review and escalate complaints that require additional review.
- File Malfunction MDR Reports as identified
- Escalate Adverse Event or Incident reports as identified
- Evaluate documentation for completeness and consistency, and assign additional actions as necessary to close the complaint file.
- Approve final complaint file for closure after all applicable actions are completed.
- Manage complaint workload to required backlog goals.
- Escalate complaints to the Regulatory Post Market Surveillance Manager or Supervisor when new failure modes are encountered
- Escalate complaints to the Post Market Investigation (PMI) group as required
- Evaluate complaints about reporting requirements per company procedures and regulatory requirements.
- Interface with internal and external sources to gather additional information required for complaint investigation, including retrieval of RMA
- Attend new hire training and continuous Regulatory Compliance training as required
- Participate in process improvement activities to continuously improve process effectiveness
- Execute on projects as required
- Perform other duties as directed
- Education: Associates Degree, Bachelor's Degree or Master's Degree
- 1+ years of experience in the medical device field, with experience or exposure in the following areas:
- Knowledge and a basic understanding of Medical Device Complaint files and quality record documentation
- Knowledge and a basic understanding of Regulatory reporting requirements for Medical Devices (US FDA requirements, EU MDD requirements, etc.)
- General technical and or clinical medical device knowledge
- General understanding of Regulatory Reporting requirements for Medical Devices and complaint system and process requirements for Regulatory Post Market Surveillance.
- General understanding of quality record requirements and how they apply to the complaint files and regulatory reports.
- Able to make decisions quickly using the information at hand and evaluate the need to obtain clarification and direction when necessary.
- Demonstrate strong written and verbal communication skills
- General computer skills (Excel, Word, PowerPoint, database)
- Efficient independent worker with the ability to focus
- Attention to detail
- Demonstrate cross-functional communication skills in email and in-person
- Organizational and analytical skills
- Ability to handle and manage workload independently
- Prioritize numerous activities in a rapid-paced environment
- Contribute to team-oriented tasks
- Analytical skills
- Interpersonal and decision-making skills.
- Detail-oriented and strong administrative skills including time management.
Amick Brown is an Information Technology consulting company specializing in ERP, Data Analytics, Information Security, Application Development, Networking, and Cloud Computing. The company was founded in 2010 and is headquartered in San Ramon, California.
Regular full-time employees are eligible for the following Amick Brown provided benefits:
- 401k with company match
- Paid time off
- Sick Leave
- Short-Term Disability
- Life Insurance
Wellness & Discount Programs