Minimum 2 years of experience in manufacturing quality assurance
Strong knowledge of ISO 13485 and regulatory compliance for medical devices
Experience applying company policies and procedures to resolve quality-related issues
Requirements:
Design, implement, and maintain quality assurance protocols and methods for processing materials into partially finished or finished products for the supply chain
Plan, implement, and manage compliance of in-house and outsourced manufacturing processes with internal and external quality and regulatory standards for global distribution
Review inspection methods, testing procedures, and evaluation techniques to ensure precision and accuracy in production processes, equipment, components, and finished products
Lead and facilitate investigations with cross-functional teams to identify root causes and implement corrective actions for product and component issues within the supply chain
Job description
Job Summary: The Manufacturing Quality Engineer is responsible for designing, implementing, and monitoring quality control programs. Key responsibilities include recommending improvements to methods, procedures, and standards to enhance output quality based on data analysis. This role ensures products meet specifications, quality standards, and regulatory compliance while tracking and resolving defects. Key Responsibilities:
Design, implement, and maintain quality assurance protocols and methods for processing materials into partially finished or finished products for the supply chain.
Plan, implement, and manage compliance of in-house and outsourced manufacturing processes with internal and external quality and regulatory standards for global distribution.
Review inspection methods, testing procedures, and evaluation techniques to ensure precision and accuracy in production processes, equipment, components, and finished products.
Analyze production reports and data trends to recommend updates or changes to quality standards and procedures.
Ensure compliance with internal and external specifications and standards such as ISO 13485, MP, and MDSAP.
Lead and facilitate investigations with cross-functional teams to identify root causes and implement corrective actions for product and component issues within the supply chain.
Provide expertise in specialized quality assurance areas, requiring knowledge of key principles and concepts.
Additional Responsibilities: Depending on experience level, responsibilities may include:
