Work Flexibility: Not available
Responsible for continuous product and process quality improvements. Ensure compliance to regulation and standards. May support investigations into NCs and CAPAs stemming from the products in the field. Knows and applies the fundamental concepts practices and procedures of the general Quality and Regulatory environment Post-Market in and analyze Post Market trending data (e.g. Q service reports complaints MDR/MIR) to identify opportunities for quality improvementSupport and communicate with complaint handling function to ensure trending information is accurate and up to post-market input and feedback on safety durability and reliability design input specifications for Quality report design reviews risk analysis and customer on PSURMay support field action related activities i.e. investigations PFAA HHEs with ISO GDP GMP desiredKnowledge of Quality Concepts (e.g. Risk Management CAPA Audits Statistics).Knowledge of statistical methods and applicationUnderstanding of US and International Medical Device Regulations
Travel Percentage: None