Quality Engineer

Job description

Job responsibilities

• Collaborate with R&D and Regulatory Affairs teams to ensure that biocompatibility requirements are met for medical devices.
• Provide guidance on sterilization processes and validations to ensure product safety and compliance.
• Facilitate sterilization activities including batch release, sterilization validation, and coordination with third party sterilizers.
• Oversee packaging validation activities to ensure product integrity and stability during storage and transportation.
• Participate in finished goods release processes, ensuring compliance with release criteria and applicable regulatory requirements.
• Oversee product quality during all stages of production in a cleanroom manufacturing environment.
• Lead and support investigations into nonconforming materials and products (NCRs), working closely with cross-functional teams including Manufacturing and Engineering, identifying root causes, ensuring timely…
• Participate in materials decision making as a member of Material Review Board

Job requirements

• Strong understanding of quality management systems.
• Excellent problem-solving skills and ability to apply root cause analysis methodologies.
• Detail-oriented with effective organizational and documentation skills.
• Strong communication and collaboration skills to work cross-functionally and interact with technicians, engineers, auditors, and third parties.
• Attention to detail, with a focus on accuracy and precision in quality-related activities.
• Ability to work independently in a fast-paced organization with competing priorities.
• Bachelor's degree in Engineering or a related technical field. Master's degree is a plus.
• Knowledge of FDA regulations, ISO 13485, and other relevant quality standards for medical devices.