Quality Compliance Specialist

Quality Compliance Specialist Contract Type:

Contractor Location:

Irvine Industry:

Pharmaceuticals Contact Name:

Emma Comeau Contact Phone:

Date Published:

27-Apr-2026

Title:

Quality Compliance Specialist Pay:

$35.00 - $40.00/hour

Location:

Irvine, CA Schedule:

Standard Office Hours Duration:

12-Month Contract The Quality Compliance Specialist is responsible for assessing complaint information, determining whether reported events meet complaint criteria, and ensuring appropriate escalation. This role supports the full complaint investigation lifecycle, ensuring compliance with regulatory requirements and internal quality standards. Key Responsibilities Assess and evaluate incoming information to determine complaint reportability and required actions Manage customer relationships and expectations throughout the complaint investigation and resolution process Conduct thorough investigations by collaborating with cross-functional teams (e.g., Product Safety, Engineering, Quality) Identify process gaps and lead initiatives to improve procedures, practices, and overall quality systems Evaluate complaints for regulatory reporting requirements (e.g., Medical Device Reporting) and prepare submissions to regulatory authorities Summarize investigation findings, including product analysis, imaging review, instructions for use (IFU), and relevant labeling or training materials Develop clear, concise conclusions and prepare final customer communications Coordinate and participate in recurring cross-functional meetings to review complaint trends, identify root causes, and track action items Ensure timely resolution of complaints and proper documentation in compliance with quality standards Additional Skills & Qualifications Experience in medical device, healthcare, or a related regulated industry required Strong proficiency in Microsoft Office and standard office tools Excellent written, verbal, and interpersonal communication skills Demonstrated problem-solving, critical thinking, and investigative capabilities Solid understanding of quality systems, policies, and compliance procedures Knowledge of medical terminology and human anatomy Familiarity with regulatory reporting requirements and complaint handling processes Understanding of Good Documentation Practices (GDP) High level of attention to detail and accuracy Ability to handle confidential information with discretion Strong organizational skills with the ability to manage multiple priorities in a fast-paced environment Ability to work independently on complex tasks with minimal supervision Education & Experience Bachelor's degree (or equivalent) in a related field 2-4 years of relevant professional experience ...