We are an engineering and manufacturing staffing agency with a niche in recruiting Quality Inspectors for clients in the Pharmaceutical and Medical Device industries. Our client is a global leader in the medical technology and surgical robotics industry, best known for developing a revolutionary robotic-assisted surgical platform that enables surgeons to perform minimally invasive procedures with enhanced precision, control, and visualization. Their innovative systems integrate 3D high-definition imaging, fluorescence-guided imaging, and AI-powered surgical analytics to improve surgical outcomes and support optimal decision-making.
In addition to their cutting-edge robotic platforms, they also design and manufacture an extensive range of surgical instruments, endoscopic tools, and accessories that seamlessly integrate with their surgical systems. This ISO-certified, FDA-registered company is dedicated to quality, safety, and continuous innovation, serving hospitals, surgical centers, and healthcare providers worldwide.
Typical Duties and Responsibilities
As a Senior Quality Inspector, you will play a crucial role in ensuring the highest levels of product quality and compliance with medical device regulatory standards. You will be responsible for inspecting complex robotic surgical systems, surgical instruments, and precision components throughout the production process.
Key responsibilities include:
- Perform detailed incoming, in-process, and final inspection of complex mechanical, electro-mechanical, and optical components for robotic surgical systems and surgical instruments.
- Conduct dimensional inspections using precision measurement tools such as micrometers, calipers, height gauges, bore gauges, pin gauges, and surface roughness testers.
- Operate and program CMM (Coordinate Measuring Machines) using platforms such as:
- Utilize advanced inspection systems such as vision systems, optical comparators, and laser measurement tools for non-contact metrology.
- Interpret engineering drawings, CAD models, and GD&T (Geometric Dimensioning & Tolerancing) specifications to ensure product compliance.
- Perform First Article Inspections (FAI) in accordance with AS9102 or equivalent protocols.
- Complete inspection reports, document non-conformances (NCRs), and collaborate with Quality Engineers on root cause analysis (RCA) and corrective actions (CAR).
- Conduct verification of assemblies for robotic-assisted surgical devices using functional test fixtures and electrical testing tools.
- Support calibration of inspection tools and equipment in compliance with ISO 17025 standards.
- Ensure compliance with medical device regulatory standards, including ISO 13485, FDA 21 CFR Part 820 (QSR), and MDR (Medical Device Regulation).
- Assist in maintaining quality records and participate in internal and external audits as needed.
- Communicate inspection results effectively to Manufacturing, Engineering, and Quality teams to drive corrective actions and continuous improvements.
Education
- High School Diploma or GED required;
- Associate’s degree or technical certification in Mechanical Inspection, Quality Control, Manufacturing Technology, or a related field preferred.
Required Skills and Experience
- Minimum 5 years of experience as a Quality Inspector within the medical device, robotics, precision manufacturing, or high-tech instrumentation industries.
- Proficient in performing complex inspections of tight-tolerance mechanical components, electromechanical assemblies, and surgical-grade materials.
- Extensive hands-on experience with precision measuring tools and digital inspection systems.
- Expertise in GD&T interpretation and blueprint reading for high-precision parts.
- Proficiency in CMM operation and programming using platforms such as Zeiss Calypso, PC-DMIS, or equivalent.
- Knowledge of ISO 13485, FDA QSR (21 CFR Part 820), and MDR regulatory requirements.
- Familiarity with First Article Inspection (FAI) processes and documentation, including AS9102 forms.
- Experience with electrical testing equipment for functional verification of electromechanical assemblies.
- Strong understanding of document control systems, quality documentation, and traceability requirements.
- Proficient in Microsoft Office Suite (Excel, Word, Outlook) and quality management systems (QMS) software platforms.
Preferred Qualifications
- Certified Mechanical Inspector (CMI) or Certified Quality Inspector (CQI) from the American Society for Quality (ASQ).
- Prior experience inspecting products for surgical robotics or advanced medical instrumentation.
- Familiarity with cleanroom inspection environments and cleanroom protocols.
- Proficiency with SolidWorks, AutoCAD, or similar CAD tools for cross-referencing drawings during inspection.
- Experience with ERP/MRP systems such as SAP, Oracle NetSuite, or Epicor for inspection tracking and inventory control.
- Hands-on experience with laser welding inspection, micro-assembly inspection, or fiber optics inspection.
