Senior QC Technical Specialist

Summary

Join Noah Medical, a leading medical robotics company, as a Sr. QC Technical Specialist. In this role, you will support manufacturing and engineering by inspecting raw and finished materials, reviewing documentation, and ensuring high-quality product production. You will also be responsible for processing non-conformances and conducting investigations. The position requires a strong understanding of QSR, ISO 13485, and Noah Medical's quality management system. A day-to-day overview includes reviewing inspection processes, performing various inspections, using sampling plans, identifying key inspection points, documenting results, and assisting with process improvement projects. This role demands strong communication, problem-solving, and teamwork skills within a fast-paced environment.

Requirements

• AS (BS preferred) in Mechanical, Industrial, Electrical Engineering or Technology, Life Sciences, or related fields preferred
• Minimum of 8+ years work experience in medical device quality control role
• Good written and oral communication skills are required and must be able to read, write, and understand English
• Good interpersonal skills dealing with other departments/ individuals in a team atmosphere are important
• Experience with performing root cause analysis
• Detail oriented and possessing a professional demeanor, be adaptable to changing environments and capable of completing tasks with little or no supervision
• Ability to read and interpret engineering DWGs, product specifications, and procedures and use metrology and other testing equipment
• Experience / skills with hand tools (caliper, micrometer, etc.)
• Experience with vision systems (MicroVu, Keyence, etc.), coordinate measuring machines, and other inspection and measurement tools
• Ability to test components, in-process subassemblies and finished products as described in engineering DWGs, product specifications, and procedures
• Proficiency / experience with MS Office suite programs (Excel, Word, PowerPoint, etc.)

Responsibilities

• Review incoming inspection processes to assure procedural compliance and recommend improvements in areas of responsibility
• Perform and review visual, dimensional and functional inspections on components as defined by specifications
• Use recognized sampling plans to determine statistical size of samples
• Ability to identify key inspection points and the proper tools / equipment to measure these points
• Use functional test fixtures for components, subassemblies, and finished devices
• Document inspection results following GMP / GDP
• Document non-conformances and ensure they are investigated and closed in a timely manner
• Perform reviews of Incoming Inspection records for GDP, Completion, and Accuracy
• Assist engineering staff with process improvement projects regarding improved quality inspection of product and components
• Communicate needs of department/company to management
• Provide/coordinate training for new QC Technician
• Other tasks as required to support the Noah Medical Quality System

Preferred Qualifications

• Preferred but not required; experience with Google Suite, ePLM/eQMS systems, MS Access, NetSuite, GD&T
• Be a self-starter, team builder, excellent in communication skills (written and verbal), organized, and able to prioritize and balance workload in a fast-paced start-up environment

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