Responsibilities: Support day-to-day medical device manufacturing operations, ensuring compliance with FDA QSR and ISO standards. Lead and execute equipment qualifications (IQ/OQ) and process validations (OQ/PQ), including cleaning and upgrade validations. Perform process characterization and develop test methods, including Test Method Validation (TMV) and Gage R&R studies. Drive root cause analysis and CAPA investigations for technical/process issues. Create and maintain controlled technical documents such as BOMs, routers, prints, and work instructions. Support a variety of manufacturing processes, including machining, casting, forging, molding, finishing, cleaning, bonding, and heat treatment. Evaluate manufacturing feasibility studies including capital equipment, capacity planning, and cost analysis. Collaborate cross-functionally to define and implement process improvement initiatives. Develop and manage project plans and timelines using Microsoft Project. Conduct PFMEA, SPC, and Critical-to-Quality (CTQ) analyses to ensure process robustness. Interface with Change Management systems and handle Nonconformance Reports (NCRs), Engineering Specifications, and CAPA documentation. Requirements: – years of experience in medical device manufacturing support. Strong understanding of GMP, design control, and regulatory requirements (FDA QSR, ISO ). Demonstrated knowledge of BOM & Router creation, engineering drawing interpretation, and statistical tools. Proficiency with tools such as PFMEA, SPC, Gage R&R, and Test Method Validation. Experienced in using Microsoft Office Suite, Excel-based data analysis, and MS Project. Familiarity with change control systems, NCRs, and CAPA processes. Working knowledge of CNC programming terminology and tooling design concepts is preferred. Strong written and verbal communication skills and ability to work collaboratively in a cross-functional team.