QA Engineer

• Develop, Implement and continuously improve the Quality Management System (QMS) in accordance with ISO 13485, FDA regulations (21 CFR Part 820), and other applicable standards and regulations. Ensures process improvement activities remain in compliance.
• Assist in developing sustainable quality control plans with detailed testing standards that can be implemented across all new product development projects, on ongoing productions and enforced by suppliers. Incorporate quality plans + inputs into design stage gates and facilitate understanding of testing and quality variables among designers, engineers, 3rd party inspectors, and suppliers.
• Create, implement, and continuously improve quality control checklists tailored to specific products, processes, and regulatory requirements.
• Collaborates with warehouse, including 3PLs, to establish quality procedures for incoming inspection, nonconforming material, preservation of product, material and storage handling, and production/process controls.
• Interface with Customer Service to rectify quality complaints & facilitate CAPA processes. Communicate quality issues, progress on CAPA actions, and quality improvements to all relevant stakeholders within the company.
• Work closely with the cross-functional teams to understand user needs rooted in consumer insights and internal design standards so they are reflected in quality control standards.
• Coordinate testing with suppliers and 3rd party labs to ensure product performance meets consumer expectations and internal quality standards.
• Maintain in-house calibration log up to date with equipment used for in-house design verification activities.
• Devise and review specifications for new and legacy products as they relate to quality testing standards, integrate with compliance to ensure testing is performed.
• Prepare for and manage external audits and inspections from regulatory bodies and customers. Responsible for the internal quality audits program. Address findings and implement corrective actions.
• Oversee the Corrective and Preventive Actions (CAPA) process to identify root causes of non-conformances and ensure timely and effective resolution.
• Drive quality improvement processes to identify and address high return rates on products and/or underperformance (for example, low star ratings)
• Evaluate and monitor suppliers to ensure they meet the company’s quality standards. This includes conducting supplier audits and managing supplier non-conformances.
• Lead, mentor, and develop the quality team to ensure alignment with company goals, regulatory requirements, and continuous improvement initiatives. Foster a culture of accountability, collaboration, and proactive problem-solving within the team.
• Provides subject matter expertise in quality engineering such as: risk management and risk assessments, design verification, equipment qualification, process validation, design transfer, configuration management, and change control.
• Develop and implement training programs and ensure employees are kept up to date with current standard operating procedures (SOPs), regulatory requirements, and company policies.
• Other projects as assigned.

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