Product Compliant Quality ManagerHydrogen Group • Boston, MA, US
No longer accepting applications
Product Compliant Quality Manager
Hydrogen Group • Boston, MA, US
1 day ago
Job type
- Temporary
Job descriptionBachelor'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. 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.
Title : Product Compliant 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 :
Preferred Skills :
Create a job alert for this search
Product Manager • Boston, MA, US