Quality Engineer (Medical Device) - Intellectt INC

Job Title: Quality Engineer (Medical Device)
Duration: 12+ Months (W2)

Job Description:
We are seeking an experienced Quality Engineer to support quality assurance activities in the medical device industry. This role will focus on maintaining and improving product quality standards, ensuring compliance with industry regulations, and supporting ongoing quality projects. The ideal candidate will have strong knowledge of medical device regulations, quality systems, and process validations.

Key Responsibilities:
Quality System Maintenance: Implement, monitor, and maintain quality systems in compliance with FDA, ISO 13485, and other regulatory standards.
Process Validation: Conduct validation activities (IQ/OQ/PQ) for processes, equipment, and test methods, ensuring compliance with established protocols and procedures.
CAPA Management: Lead root cause analysis, corrective and preventive actions (CAPA), and other quality improvement projects.
Product Quality Assurance: Perform inspections, audits, and quality reviews to ensure product quality standards are met consistently.
Supplier Quality Management: Collaborate with suppliers to maintain and improve material quality, oversee supplier quality audits, and implement supplier corrective actions.
Document Control: Ensure accurate and timely documentation of quality processes, validation protocols, risk assessments, and test results.
Data Analysis & Reporting: Analyze quality data to identify trends, generate reports, and recommend continuous improvements.

Qualifications:
Education: Bachelor's degree in Engineering, Life Sciences, or a related field.
Experience: Minimum of 3 years of experience in quality engineering, ideally in the medical device or life sciences industry.
Regulatory Knowledge: In-depth understanding of FDA regulations (21 CFR Part 820), ISO 13485, and other applicable medical device regulations.
Validation Expertise: Hands-on experience with process validation (IQ/OQ/PQ) and familiarity with statistical analysis tools (e.g., Minitab).
Problem-Solving Skills: Proven ability to lead root cause analysis and implement effective CAPA processes.
Technical Skills: Proficiency with quality management software (e.g., TrackWise, MasterControl) and data analysis tools.
Communication Skills: Strong written and verbal communication skills with the ability to collaborate cross-functionally and liaise with suppliers.