Senior Manufacturing Quality Engineer

Summary

Join Noah Medical, a leading medical robotics company, as a Senior Manufacturing Quality Engineer - Disposables. In this role, you will provide hands-on leadership and guidance in quality and regulatory aspects throughout the product development cycle, focusing on V&V and Design Transfer. You will collaborate with cross-functional teams to ensure efficient manufacturing operations, optimize production schedules, and maintain high-quality standards. Responsibilities include developing and supporting product acceptance processes, engaging in procedure validation and improvement, and providing training on Noah Medical’s Quality Management System. The ideal candidate possesses a BS degree in a technical field and 6+ years of engineering experience in the medical device field, including 4+ years in a QE/Mfg. function. This position offers a competitive salary and benefits package, including health insurance, 401K, stock purchase plans, paid time off, and flexible work arrangements.

Requirements

• BS degree in a technical field or equivalent
• BS in Engineering or Technology, Mechanical, Industrial, Electrical, Manufacturing, Life Sciences, or equivalent
• Minimum of 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

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 (including sterilization), and finished product release activities
• Participate in new product development teams and represent Quality function as needed. Provide relevant input to the product development planning process according to project milestones and QMS implementation /requirements/trace matrix
• Define, implement, and provide training on relevant aspects of Noah Medical’s Quality Management System to meet US FDA and International requirements
• 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

Preferred Qualifications

• 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

• Competitive pay
• Health insurance
• 401K and stock purchase plans
• Tuition reimbursement
• Paid time off plus holidays
• A flexible approach to work with remote, hybrid, field or office work schedules
• Comprehensive health insurance including Medical, Dental and Vision + HSA and FSA options
• Equity & Bonus Program
• Life Insurance (company paid & supplemental) and Disability insurance
• Mental health support through medical insurance programs
• Legal and Pet Insurance
• 12+ paid holidays, 15-20 days of PTO + sick time
• Paid parental leave
• In-office snacks and beverages
• In-office lunch stipend
• Learning & Development Opportunities: On-demand online training and book reimbursement
• Team building and company organized social and celebration events