2 of 2 ISO 13485 Jobs in Yorkshire

support process development initiatives. Key responsibilities: Design, develop, and optimize manufacturing processes for transfer project. Conduct process validations and ensure compliance with FDA and ISO regulations. Draft and execute IQ, OQ, PQ in cleanroom environment Collaborate with product development teams to ensure the manufacturability of new products. Monitor and … understanding of manufacturing processes in MedTech industry, including injection molding, CNC, assembly, and sterilization. Knowledge of quality management systems and regulatory requirements (e.g., FDA, ISO 13485). Proficiency in statistical analysis and process improvement methodologies, such as Lean and Six Sigma. Ability to interpret engineering drawings and technical More ❯

all Supplier generated design changes are managed and documented in a compliant manner. Ensure compliance with all Documented Quality system, FDA QSR’s and ISO 13485 requirements during day to day and assigned audit/CAPA activities. Maintain a good level of housekeeping in designated areas and observe … experience: Good technical understanding of manufacturing equipment and processes is required. In-depth knowledge and experience of product/process Risk Management (FDA and ISO standards). Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc. Strong … sound judgment is highly desired. Understanding of the NPI (New Product Introduction) process and Process Validation is preferred. A thorough understanding of GMP/ISO regulations and validation regulations is preferred. Strong mentoring, coaching and leadership skills are required. Demonstrated project management and project leadership abilities. Rewards & Benefits TCS More ❯