Staff Supplier Quality Engineer

Neptune Medical is a venture backed medical device company based in Silicon Valley. We design, manufacture, and commercialize medical devices based on our proprietary Dynamic Rigidization™ technology. Pathfinder® is our first FDA-cleared commercial device incorporating this novel technology. This advanced endoscopy device is being used at a growing list of leading U.S. hospitals and academic medical centers. Now, the team at Neptune is building something truly unique: a fully flexible medical robot that enables doctors to reach deep into human anatomy. Our Triton robot will disrupt flexible endoscopy and set a new standard with Triton Robotic Endoscopy in outcomes for decades to come.

TITLE: Staff Supplier Quality Engineer

POSITION SUMMARY:

We are seeking an experienced and skilled Staff Supplier Quality Engineer to ensure that all materials, components, and services provided by suppliers meet rigorous medical device industry standards and regulatory requirements. This role leads supplier qualification, development, and performance monitoring, working cross-functionally to resolve quality issues, drive continuous improvement, and maintain compliance with FDA, ISO 13485, EU MDR and related standards. The position requires strong technical expertise, proactive supplier management, and the ability to influence both internal teams and external partners

The ideal candidate would act with passion and intensity in a medical device start-up that is fast paced and collaborative and display the ability to perform to the requirements outlined below. For the right person, this position will be a tremendously exciting and career-defining opportunity, making core contributions to a genuinely new type of medical robotic platform.

ROLES AND RESPONSIBILITIES:

• Act as a liaison between Neptune Medical and our suppliers
• Plan, schedule, execute, report, and follow-up on supplier audits to drive process standardization, waste elimination, and continuous improvement
• Establish specific short- and long-term supplier quality goals
• Execute the organizational objectives and programs to reduce total costs
• Initiate, issue, review, and approve Supplier Corrective Action Reports (SCARs)
• Support problem solving and root cause analysis activities with suppliers to eliminate recurrence of non-conformances
• Partner with design and manufacturing quality engineers to investigate and resolve supplier-related technical issues in a timely manner to ensure continuity of supply
• Support manufacturing operations, manage suppliers, and work with cross-functional groups to address quality issues
• Proactively collaborate with suppliers to identify and execute data driven continuous improvement projects
• Lead Material Review Board (MRB) meetings
• Review, investigate, disposition, and drive to completion Non-conforming Reports (NCRs) and Corrective and Preventive Actions (CAPAs)
• Maintain supplier performance metrics and scorecards
• Partner with Engineering, Operations, and R&D in the evaluation and qualification of new suppliers
• Strategically lead supplier performance improvement projects to increase supplier capabilities
• Assist with management and monitoring of key performance indicators (KPIs) related to supplier quality
• Coordinate timely completion of supplier evaluations and supplier control activity records
• Comply with internal and external quality requirements for supplier management
• Model a culture of quality within the organization
• Travel up to 20–25% to supplier sites for audits, assessments, and ongoing supplier development

REQUIRED QUALIFICATIONS:

• B.S., in a related engineering discipline; 12+ years total industry experience in manufacturing of electro-mechanical systems/products/solutions for the medical, aerospace or automotive industries
• Experience working across functional areas and possess an understanding of the various operational disciplines, e.g., Engineering, Manufacturing, Logistics, Purchasing, Supply Chain
• Strong oral and written presentation skills and ability to communicate technical information to a non-technical audience
• Ability to interact with principal business owners or senior management staff at the supplier to discuss projects and resolve problems
• Knowledge of medical device regulations, risk management, validations, and root cause analysis
• Expertise in supplier audits, supplier performance metrics, and maintaining supplier quality records
• Comfortable working in fast-paced start-up environment with ownership and accountability for the entire supply chain
• Ability to work independently and as part of a team.
• Strong problem-solving and decision-making abilities.
• Proactive and able to manage multiple projects simultaneously.
• Strong leadership, communication, and organizational skills.
• Willingness to adapt to changing needs and priorities.
• Proficiency in Microsoft applications.
• Eagerness to learn new things. 

Neptune Medical is located in Burlingame, CA, near the Millbrae Caltrain and BART Station

Our job titles may span more than one career level. The starting base salary for this role is between $180,000 and $210,000 depending on experience. The actual base pay is dependent upon many factors, such as: education, training, transferable skills, work experience, business needs, and location. The base pay range is subject to change and may be modified in the future. This role may also be eligible for equity, benefits and 401(K) with matching.

Neptune Medical provides equal employment opportunities to all applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.