Job Description
Responsibilities:
Provide quality engineering support throughout the product development lifecycle by applying ISO , ISO , and FDA design control principles to ensure compliance.
Serve as a Subject Matter Expert and own Risk Management (Hazards Analysis and FMEAs) across the assigned product / product families (mainly complex electro-mechanical devices).
Support design verification, validation, and reliability testing.
Participate in supplier qualifications.
Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements, supporting design transfer activities.
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Support audits, CAPA investigations, and continuous improvement initiativ...