Job Description

Title: Product Complaint Quality Manager

Location: Boston - Fan Pier

Pay: $70.00-$75.00

Schedule: Standard Office Hours

Duration: 12-Month Contract

Job Description:

The Product Complaint Manager supports the Quality System by overseeing all aspects of product complaint management within the organization's small molecule, biologics, and device portfolios. This role partners cross-functionally with internal and external stakeholders-including Patient Safety, Supply Chain, Medical Information, Quality Assurance, Contract Manufacturing Organizations, and Call Centers-to ensure timely, compliant, and effective resolution of product complaints.

Key Responsibilities:

• Support product complaint lifecycle activities, including intake, triage, reconciliation, trending, sample management, training, and SOP updates.
• Conduct and document product complaint investigations, coordinating with Contract Manufacturing Organizations for external follow-up as required.
• Perform quality review of complaint investigations completed by other team members to ensure accuracy, completeness, and compliance.
• Compile and analyze complaint metrics and author quarterly trending reports.
• Deliver cross-functional training on complaint processes and participate in related quality system activities, including deviation management and CAPA development.
• Assess and implement changes to procedures based on new regulatory intelligence or quality system improvements.
• Represent the product complaint function in internal and external meetings, audits, and inspections.

Minimum Requirements:

• Bachelor's degree in a scientific or allied health field and 8+ years of relevant experience, or a Master's degree with 3-4 years of relevant experience.
• Proven background in Quality Assurance roles supporting complaint management, root cause analysis, and CAPA in biologics, medical devices, or pharmaceuticals.

Preferred Skills:

• Strong understanding of GMP/GDP and regulatory requirements (21 CFR 820, ISO 13485).
• Experience managing cross-functional projects and complex investigations.
• Excellent technical writing and communication skills.
• Demonstrated analytical, problem-solving, and critical-thinking abilities.
• Ability to thrive in a fast-paced, collaborative environment.

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