Orchid Orthopedic Solutions is seeking a Quality Engineering Tech to support high-precision orthopedic implant manufacturing in a regulated medical device environment. You will perform in-process and final inspections, execute tests, and document results to meet FDA and
ISO 13485
requirements. Working closely with engineering and operations, you'll help analyze defects, support CAPA, and drive continuous improvement. This role offers hands-on experience with advanced metrology tools, robust training, and collaboration across sites focused on patient impact, safety, and product quality. Responsibilities Perform in-process and final inspections of orthopedic components and assemblies Execute dimensional measurements using gauges, CMMs, and other metrology tools Support validation and verification testing for processes and products Document results in accordance with
FDA, ISO
13485, and internal quality procedures Assist engineers with root cause analysis and corrective/preventive actions (CAPA) Maintain inspection records, device history records, and quality reports Collaborate with production to resolve nonconformances and reduce defects Support calibration and maintenance of inspection and test equipment Participate in continuous improvement and lean/quality projects Follow safety procedures and cleanroom/controlled environment protocols Required Skills Quality inspection Dimensional metrology CMM operation GD&T interpretation
ISO 13485
compliance FDA medical device regulations Root cause analysis CAPA processes Statistical process control (SPC) Technical documentation