Quality Assurance Engineer

The Quality Assurance Engineer will support the organization towards compliance of Corporate Quality and Environmental policies, provide leadership, expertise, and guidance for all Quality and Regulatory activities, and assist with required quality and technical tasks.

Essential Duties & Responsibilities

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• Ensure compliance with FDA, ISO 13485, and other relevant regulatory standards for medical device manufacturing.
• Develop and implement quality management system documents for product design, development, and manufacturing.
• Conduct internal and external audits of quality systems to ensure adherence to quality standards.
• Coordinate the activities for Quality Management System (QMS) review and present the supporting data and metrics
• Review and approve manufacturing process changes impacting product quality, including changes to equipment and software
• Participate in risk management activities (FMEA, risk analysis) to identify potential product risks and implement corrective actions.
• Manage non-conformances, CAPA (Corrective and Preventive Action) processes, and root cause analysis.
• Collaborate on the investigations of customer complaints, ensure timely and accurate closure and issue reports back to affected customers.
• Work with cross-functional teams to resolve quality issues, including R&D, manufacturing, and regulatory departments.
• Develop and maintain quality documentation, including process validation protocols, technical reports, and device history records.
• Monitor and analyze quality data to identify trends and drive continuous improvement initiatives.
• Co-lead with R&D and Manufacturing Engineering the product, process and software validation activities (IQ, OQ, PQ) to ensure the product meets the required specifications.
• Co-lead with Sourcing the supplier qualification process and conduct regular audits to ensure that supplied components and raw materials meet quality requirements.
• Manage SCAR (Supplier Corrective Action Request) process to address and resolve quality issues arising from suppliers.
• Provide the tools and training on quality systems and procedures for internal teams.
• Ensure proper calibration and maintenance of quality inspection equipment.
• Other duties as assigned

Qualifications

• Bachelor’s degree in engineering (Mechanical, Electrical, Computer, Biomedical, Industrial, or related field) or equivalent experience.
• 5+ years of experience in quality assurance/quality engineering in a medical device or related industry.
• Strong understanding of regulatory requirements, including FDA 21 CFR 820, ISO 13485
• Experience with quality management systems, audits, and compliance.
• Experience with MasterControl eQMS is a plus.
• Proficiency in root cause analysis and corrective action (CAPA) processes.
• Strong analytical and problem-solving skills.
• Excellent verbal and written communication skills.
• Certified Quality Engineer (CQE) or equivalent certification is a plus.
• Familiarity with Six Sigma, Lean manufacturing, or other process improvement methodologies is a plus.
• Ability to manage multiple projects and work in a fast-paced environment.
• Knowledge of statistical process control (SPC) and other quality control tools is a plus.
• Proficiency in quality-related software tools (e.g., Minitab, QMS systems) is a plus.