Product Complaint Analyst II

Product Complaint Analyst II

Schedule:

Monday-Friday | 8:00 AM - 5:00 PM | Hybrid after training (3 days remote, 2 days onsite)

Overview

We are seeking a detail-oriented Product Complaint Analyst II to join a growing Quality team supporting a high-priority complaint remediation and investigation initiative. This role is responsible for reviewing, investigating, documenting, and closing product complaints while ensuring compliance with FDA regulations, GMP requirements, and internal quality standards.

The ideal candidate will have experience in complaint handling, quality systems, and regulated environments such as medical devices, IVD, pharmaceuticals, or biotechnology. Success in this role requires strong analytical skills, excellent documentation practices, and the ability to manage multiple investigations in a fast-paced environment.

Key Responsibilities

+ Review, evaluate, and investigate product complaints to determine reportability, impact, and required actions.

+ Conduct thorough complaint investigations, including data gathering, root cause analysis, and documentation of findings.

+ Complete and maintain complaint records in accordance with FDA, GMP, and company quality system requirements.

+ Support risk assessments and quality decision-making related to customer complaints and product performance concerns.

+ Collaborate with Quality Assurance, Regulatory Affairs, Manufacturing, Technical Support, and Operations teams to drive timely complaint resolution.

+ Manage multiple complaint investigations simultaneously while meeting established timelines and quality objectives.

+ Ensure documentation accuracy, completeness, and compliance throughout the complaint handling process.

+ Contribute to complaint backlog reduction, remediation projects, and continuous improvement initiatives.

+ Support quality system activities including CAPA, adverse event evaluation, trend analysis, and corrective action implementation as needed.

Required Qualifications

+ Bachelor's degree in Biology, Chemistry, Biotechnology, Life Sciences, Engineering, or a related scientific discipline preferred.

+ Minimum 2-4 years of experience in complaint handling, quality assurance, quality systems, or regulated manufacturing environments.

+ Experience conducting investigations and documenting findings within FDA-regulated industries.

+ Working knowledge of GMPs, quality systems, complaint management processes, and regulatory compliance requirements.

+ Strong written and verbal communication skills with exceptional attention to detail.

+ Ability to prioritize competing responsibilities and manage a high-volume workload effectively.

+ Proficiency with Microsoft Office applications, particularly Excel and Word.

Preferred Qualifications

+

Experience with in medical device, IVD, biotechnology, pharmaceutical, or other highly regulated industries.

+ Familiarity with complaint management and quality systems software such as Salesforce, Track Wise, Master Control, or similar platforms.

+ Experience supporting complaint remediation efforts, backlog reduction initiatives, or large-scale quality projects.

+ Knowledge of CAPA, adverse event reporting, risk management, and post-market surveillance processes.

+ Experience participating in cross-functional investigations and root cause analysis activities.

Work Environment

+ Hybrid work schedule available following completion of initial onsite training.

+ Collaborative team environment partnering with Quality, Regulatory, Technical Support, and Operations functions.

+ Fast-paced setting focused on complaint investigations, documentation excellence, and compliance-driven outcomes.

+ Opportunity to contribute to critical quality initiatives that directly impact product performance, customer satisfaction, and regulatory compliance.

Why Join the team?

This is an excellent opportunity to join a dynamic quality organization focused on driving product excellence and operational improvement. You'll gain exposure to complex investigations, cross-functional collaboration, and quality system processes while making a meaningful impact in a regulated environment.

Job Type & Location

This is a Contract position based out of San Diego, CA.

Pay and Benefits

The pay range for this position is $36.25 - $45.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

- Medical, dental & vision
- Critical Illness, Accident, and Hospital - 401(k) Retirement Plan
- Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and…