Product Quality Engineer – Post Market Quality

Intellectt Inc is seeking a Product Quality Engineer to support post-market quality activities for medical devices in a regulated environment. This role focuses on complaint investigations, root cause analysis, CAPA, risk assessments, and continuous improvement initiatives for on-market products.

Responsibilities:

• Lead complaint investigations, root cause analysis, and post-market quality activities for medical device products
• Evaluate complaints, field issues, and trending data to identify product risks and recurring quality concerns
• Conduct Health Risk Assessments (HRA) and support risk management activities
• Drive CAPA implementation and support corrective/preventive action effectiveness reviews
• Partner with Quality, Engineering, Manufacturing, Operations, Regulatory, and R&D teams on investigations and improvement initiatives
• Perform failure analysis, data analysis, and complaint trending to identify quality trends and reliability issues
• Support design or process changes including change control documentation, testing, and drawing revisions as needed
• Develop and improve test methods for complaint investigations and failure analysis
• Present investigation findings, quality metrics, and recommendations to leadership and stakeholders
• Support audits, FDA inspections, supplier audits, and regulatory compliance activities
• Provide technical guidance to complaint handling teams and support complex investigations

Requirements:

• Bachelor's degree in Mechanical, Biomedical, Electrical, Biomechanical Engineering, or related discipline
• 5+ years of experience in FDA-regulated industries, preferably medical devices
• Strong experience with complaint investigations, CAPA, root cause analysis, and post-market quality systems
• Knowledge of FDA QSR, ISO 13485, Design Controls, EU MDR, GMP, GDP, and risk management principles
• Experience using quality investigation tools and analytical problem-solving methodologies
• Strong communication, technical writing, and cross-functional collaboration skills
• Ability to work independently in a fast-paced regulated environment
• Experience in product development, R&D, or design engineering
• Familiarity with V&V, reliability testing, DOE, statistical analysis, and test method validation
• Knowledge of sterilization, packaging, electrical safety, biocompatibility, and reliability standards
• Experience with risk-based analysis and product specification development