Job Description

Noah Medical is seeking a highly motivated and experienced Sr. Manufacturing Quality Engineer to provide hands-on guidance and leadership from a Quality and Regulatory perspective throughout the product development cycle, especially with V&V and Design Transfer stages. The role involves collaborating with cross-functional teams to ensure efficient manufacturing operations, optimize production schedules, meet customer demands, improve processes, support NPI, scale production, improve the factory, own safety and facilities, while maintaining high-quality standards.

Responsibilities

• Develop and support Product Final Acceptance processes
• Engage in procedure validation and improvement activities
• Provide hands-on leadership and guidance to Design Transfer requirements, Risk Management, Manufacturing processes, incoming and in-process inspection, test methods/specifications, Process Validation, and finished product release activities
• Participate in new product development teams and represent Quality function as needed
• Define, implement, and provide training on relevant aspects of Noah Medical’s Quality Management System
• Grow in QE/QMS expertise as defined by the manager
• Participate in QE/QMS activities not specified here and as assigned
• Review equipment documents and ensure all defined requirements are met
• Collaborate well with team members throughout Noah organization
• Support Good Manufacturing Practices and quality management system in accordance with FDA regulatory and ISO 13485 requirements
• Other related assignments and support for manufacturing

Requirements

• BS degree in a technical field or equivalent
• 6+ years of Engineering work experience in the medical device field and a minimum of 4 years’ experience in a QE/Mfg. function or equivalent
• Experience in production environments that meet world class regulatory requirements such as ISO/FDA Quality Management System requirements
• Experience in inspection/test method development and validation for IQC, In-Process, and Final release requirements
• Experienced with Process Validation including sterilization validation
• Experience in supplier selection, qualifications and improvement
• Experience with Risk Analysis, FMEAs, Hazard Analysis
• Experienced with statistical skills to define/train on test sample size and data analysis techniques
• Experienced in Microsoft Office and other software tools such as Google Suite and ePLM/eQMS systems, or equivalent
• Must have attention to details, be a self-starter, a team builder, and excellent in verbal and written communication
• Prior manufacturing experience in a medical device company, preferably on surgical robotics or equivalent highly complex medical devices
• Strong team player with proven history of success working in a multi-disciplinary, cross functional team
• Strong verbal and written skill with the ability to communicate effectively across functions and levels in the organization
• Excellent people and project management skills
• Experience in MRP systems, MS office and related office automation systems
• Experience in Medical Device Design Control processes preferred
• Experience with sterilization processes

Benefits

• No benefits