About The Team

Join our Quality team at Noah Medical, where you'll play a pivotal role in driving innovation and product leadership in medical robotics. We're a hands-on, technical, and solution-oriented, and accountable team, seeking like-minded individuals to join us. Utilizing a data-driven approach, we tackle challenges and fuel innovation. Committed to exceeding FDA and international regulatory standards, we take initiative, optimize processes, and implement agile quality management systems to foster continuous improvement. Our ultimate goal is to make a meaningful impact on patients' lives by setting new benchmarks and breaking barriers in the field of medical robotics. Come join us as we shape the future together! 

This position is responsible for ensuring product quality throughout the design lifecycle while serving as a key liaison between Engineering and the Service organization. This role drives design robustness, field performance improvement, and customer satisfaction by proactively incorporating serviceability, reliability, and field feedback into product development and continuous improvement initiatives. We are looking for someone that is highly motivated and solution oriented; you must be a self-starter, team builder, and excellent communicator. This is a 6-month contract opportunity. 

A Day In The Life Of Our Contract Sr. Design Quality Engineer-Service at Noah Medical

• Act as the primary quality liaison to the Service organization. 

• Support Design for Reliability (DFR), Design for Manufacturability (DFM), and Design for Serviceability (DFS) initiatives. 

• Review hardware and system-related verification and validation strategies for the Service organization and ensure timely execution.   

• Co-develop the project process validation strategy and review IQ/OQ/PQ/TMV protocols for service tools, equipment, software, and field processes. 

• Participate in development activities, including design reviews, requirements analysis and tracing, and configuration management. 

• Serves as a technical resource for risk management activities for hardware and systems in compliance with ISO 14971 and IEC 60601.   

• Review test plans, and test cases based upon the product and component level requirements, ensuring that appropriate statistical techniques are applied. 

• Review and approve V&V system maintenance such as reworks and modification and tracking. 

• Partner with cross-functional teams to collaborate on root cause analysis of identified design issues and identify appropriate corrective and preventive action.  Use the NC and CAPA systems as needed to structure activities. 

• Support field service engineering requests and assess serviceability risks. 

• Partner with PMO to apply project management tools to define project deliverables and establish a project schedule. 

• Foster a culture of quality throughout the organization by sharing best practices and promoting quality awareness. 

About You

• BS in Engineering or Technology, Mechanical, Industrial, Electrical, Life Sciences, etc. 

• Minimum of 4 years of Engineering work experience with a BS in the medical device or similarly regulated industry or minimum of 2 years of Engineering work experience with a PhD.    

• Preferred 2 years experience in a development QE function in a regulated environment 

• Experience in meeting Design Control and DHF requirements with R&D teams. 

• Experience with Quality Management System to meet US FDA and ISO/MDR requirements. 

• Experience with Risk Management, FMEA, Hazard Analysis, GD & T requirements. 

• Experienced with statistical skills to define/train on test sample size and data analysis techniques. 

• Experienced in Microsoft Office, Google Suite, Jama, and ePLM/eQMS systems. 

• Must be a self-starter, team builder, and excellent in verbal and written communication. 

• Preferred: Experience working in a clinical setting, and or field service 

• Preferred: Certifications: CQE, CQA(BM), CQM, 6 Sigma, etc 

#LI-Hybrid

A Day In The Life Of Our Sr. Product Quality Engineer at Noah Medical

• Able to lead efforts into the investigation of returned field devices, including flexible endoscopes, disposable devices, and capital devices/equipment
• Take the lead on methodical root cause analysis projects. Document the findings in clearly written reports/presentations
• Review engineering drawings, understand their impact on parts received, and propose opportunities for design improvements
• Design of test methods and fixtures in order to facilitate efficient study of returned devices
• Mentor less experienced engineers in the process of effective root cause analysis.
• Collaborate with design, manufacturing, and quality teams to drive consistent, high-quality parts and assemblies

About You

• B.S. or M.S. in mechanical engineering or related engineering discipline
• Min 7 years of experience in the medical device industry
• Demonstrated history of applying creative problem solving ability to difficult technical problems
• At least 5 years of leading root cause efforts of clinical context and use of medical devices
• Ability to manage and analyze large sets of data and effectively communicate results of data analysis.
• Proficient in use of CAD 
• Experience assessing products produced by various fabrication methods used in single use, complex medical devices(e.g. machining, plastic injection molding, MIM, laser cutting, stamping, rapid prototyping). 
• Demonstrated ability to work and mentor successfully in a team environment.
• Demonstrated strong project management skills.
• Eagerness to learn and to contribute to state of the art technology 

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About The Team

The Director of RA/QA reports to the Head of Quality and Regulatory. This position is the day to day leader of the RA/QA function and provides guidance and leadership from a Regulatory and Quality perspective to the team throughout all stages of product development.  We are looking for someone that is highly motivated in their career growth (possible vertical and horizontal growth to take on wider roles as well); must be a self-starter, team builder, and excellent in communication.

A Day In The Life Of Our Director, Quality Assurance and Regulatory Affairs at Noah Medical

• Establishes RA/QA department operational objectives/budgets, manages staff hiring, assignments, performance feedback, and coaching to support company milestones. 
• Involved in developing, modifying and executing RA/QA related company policies, which affect immediate operation(s) and may also have company-wide effect. 
• Manages the RA/QA department functions through direct reports or subordinates.
• Regularly interacts with senior management of other functional areas, suppliers, and/or customers using soft skills to collaborate, think outside of the box, problem solve and gain acceptance of others in sensitive situations. 
• Supports defining, training and implementing the quality management system (QMS) at Noah Medical and the ongoing maintenance of the QMS to ensure that the quality system is properly documented and revised as necessary to assure continued compliance with US and International regulatory requirements.  
• Coordinates the planning and organization of regulatory activities related to Design/Development/NPI, manufacturing, distribution control, and service
• Manages the reporting and investigation of customer/service complaints, the review of corrective actions and failure investigations, the review of Post Market Surveillance reporting and, if necessary, implements field corrective actions. 
• May serve as the designated Management Representative. 

About You

• Requires a BS (preferably in Engineering or Technology) with a focus in Mechanical, Industrial, Manufacturing, Electrical, Life Sciences, etc. 
• Minimum of 10 years of RA/QA related experience in the medical device field (experience in capital equipment and services a plus)
• Minimum of 3 years of supervisory experience of multiple exempt level employees.
• Experience working in a startup environment to meet rigorous timelines with NPI and product launch teams.
• Experienced in implementing a complete QMS system to meet US FDA and ISO requirements.
• Experienced in conducting internal and supplier audits and hosting 3rd party audits.
• Must be a self-starter, team builder, and excellent in verbal and written communication.
• Preferred: Knowledge of sterile/disposable medical device production processes.
• Preferred: Master Degree, MBA, experienced with Software Validation, 
• Certifications is a plus: CQE, CQA(BM), CQM, 6 Sigma, ISO Auditor, etc. 

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