General Completes work assignments under limited supervision/guidance. Interfaces with R&D, Regulatory Affairs, Clinical, Medical Safety, Complaints Management Centres and Post Market Quality Assurance team environment providing technical and quality systems input. Familiarity with requirements and procedures that govern medical device Design Control, Risk Management and Post Market Surveillance. Seeks to support improvements in product and process quality. Builds Quality into all aspects of work by maintaining compliance to all quality requirements. Excellent interpersonal and communication skills with good leadership abilities. Provides both quality and technical input to ongoing product development, product sustaining and post-market commercial product activities. Provides design quality support in the resolution of PIRs, complaints investigation, CAPAs, VIPs, and regulatory requirement changes. Analyses, draws conclusions and makes appropriate decisions from risk management activities and test data. Experienced in post-market (complaints) support, risk management, design and process change, standards compliance (to regulatory requirements). Minimum of Bachelor of Science Degree Level 8 in Engineering/Technology. 2/3 years' experience in a manufacturing environment or equivalent with direct experience in a QA environment (preferably GMP regulated). Experience in the medical device industry is an advantage.