Quality Engineer

Responsibilities

Support Quality Management System (QMS) processes in compliance with FDA, ISO 13485, and company quality standards.
Assist with investigations involving nonconformances, deviations, complaints, and CAPAs.
Participate in root cause analyses and implementation of corrective and preventive actions.
Support manufacturing and product quality initiatives to ensure compliance and continuous improvement.
Review quality documentation, engineering changes, and manufacturing records.
Assist with validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports.
Collaborate with Engineering, Manufacturing, Operations, and Supplier Quality teams to resolve quality issues.
Support internal audits, supplier audits, and regulatory inspections.
Collect and analyze quality metrics and identify trends for improvement opportunities.
Participate in risk management and design control activities throughout the product lifecycle.
Assist with supplier qualification and supplier performance monitoring activities.
Maintain documentation in accordance with FDA regulations, ISO 13485 requirements, and Good Documentation Practices (GDP).

Qualifications

Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, Industrial Engineering, Quality Engineering, or a related technical field.
0–5 years of experience in Quality Engineering, Manufacturing Engineering, Validation Engineering, or a related role within a regulated industry.
Internship, co-op, or full-time experience within medical devices, pharmaceuticals, biotechnology, or other regulated manufacturing environments is highly preferred.
Basic understanding of FDA Quality System Regulations (21 CFR Part 820), ISO 13485, and Good Manufacturing Practices (GMP).
Exposure to validation activities including IQ, OQ, and PQ preferred.
Familiarity with CAPA, nonconformance investigations, and root cause analysis methodologies is a plus.
Strong analytical and problem-solving skills.
Excellent written and verbal communication skills.
Ability to work effectively in a cross-functional team environment.

Quality Engineer

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