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Abbott · 5 hours ago

Instrument Quality Engineer

United States - Maine - South Portland

Full-time

Onsite

Mid Level

$61K/yr - $123K/yr

Abbott is a global healthcare leader that helps people live more fully at all stages of life. The Instrument Quality Engineer will play a key role in maintaining and improving the quality system, ensuring product excellence and compliance through various quality processes.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

Responsibilities

Assist with the administration of, and ensure compliance in maintaining the quality system and may be responsible for one or more of the following processes: Batch Release, Complaint Coordination, Metric Maintenance, Surveillance Program, Testing Program, Document Control, Exception Report and CAPA System, Batch and Sample Retention and Maintenance

Actively monitor Third-Party Manufacturers’ data and Support areas for compliance with internal Standard Operating Procedures (SOPs) and relevant regulatory requirements (cGMP, ISO)

Review GMP-related documentation for compliance, including batch records and associated manufacturing, testing, and release data; validation protocols and reports; labels; product specifications; and additional documentation as required

Participate in the Corrective Action/Preventive Action (CAPA) process, including investigations of failures or deviations in the Manufacturing area, as needed

Maintain product complaint logs to identify and report recurring issues to Quality Assurance management and product development. Collaborate with internal teams to address product inquiries and issues

Write and revise SOPs, controlled forms, and related documents to ensure best practices and alignment with current operations

Collaborate with members of the Quality Assurance team on special projects

Participate on permanent and temporary process- or project-driven teams

Develop familiarity and subject matter expertise in electronic support systems such as TraqWise, GQMS, Team Center, Compliance Wire

Collect, analyze, and publish quality metrics

Provide data to support budgetary submissions

Assist with other support duties as assigned