Complaints Analyst

inSync Staffing; San Diego (CA); On-site; USD 60,000 - 90,000; Full time

Benefits offered by this job

Health insurance

Health savings account

Vision insurance

Flexible spending accounts

Life insurance

Job summary

inSync Staffing is seeking a QA/Regulatory Affairs professional for a 3-month assignment in the San Diego area to support product quality activities, complaint investigations, and cross-functional collaboration. You will review cases for adverse events, ensure GMP-compliant records, and assist with CAPA and escalation processes.

The role emphasizes monitoring, documentation, and timely communication. Bachelor's degree and 1–3 years in QA/Regulatory Affairs in a medical device company are

Qualifications

• Bachelor's Degree required.
• 1–3 years of QA/Regulatory Affairs experience in a medical device company.

Responsibilities

• Review cases and assess potential adverse events for timely escalation to Regulatory.
• Evaluate complaints with assessment, investigation, containment, and escalation decisions.
• Ensure complaint records meet GMP standards (investigations, CAPA, NCs).
• Participate in monitoring activities of the Quality Assurance escalation mailbox.
• Facilitate evaluation of complaints including assessment, investigation, containment, review and approvals.
• Support complaint investigations and resulting CAPA activities.
• Complete other activities as assigned.

Skills

Regulatory Affairs

Quality Assurance

GMP

Education

Bachelor's Degree

Job description

3 month assignment with potential to extend

Summary

Participate in product quality activities, for complaint investigations of company products. Facilitates cross functional discussions in identifying, documenting, analyzing and reporting quality issues and ensuring that customer feedback is appropriately evaluated. Facilitate functional area initiatives as needed. Provide colleagues support as needed.

Key Responsibilities

• Reviews individual cases, assess for potential adverse events for escalation to Regulatory in a timely manner
• Reviews individual for the evaluation of complaints, including assessment, investigation, containment, for determination of escalation
• Ensures adequacy of complaint records to GMP Standards (e.g. investigations, CAPA, NCs)
• Participates and conducts tasks associated with rotational “monitor” activities of Quality Assurance escalation mailbox
• Facilitates the evaluation of complaints, including assessment, investigation, containment, review, approval and determination of on-going needs
• Participates, facilitates, and/or supports complaint investigations and resulting CAPA activities
• Completes other activities as assigned

Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

Qualifications Minimum Requirements

• Bachelor's Degree
• 1-3 years recent experience in Quality/Regulatory Affairs in a in vitro diagnostics device or medical device company

Must Have:

Nice To Have:

• Analysis of adverse events and product quality complaints
• Basic understanding of QMS, experience working with QM master data, any experience Around nonconformances and material containment
• Complaint Management
• Complaint Monitoring
• Complaints Analysis

Benefits:(employee contribution)

• Health insurance
• Health savings account
• Vision insurance
• Flexible spending accounts
• Life insurance

We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment-qualified applicants with arrest and conviction records. For Los Angeles, CA applicants: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.