Co - op Student - Customer Quality Engineer
Stryker
Post-Market Quality Assurance Manager
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 particular.
• Gather and analyze Post Market trending data (e.g. Q, service reports, complaints, MDR/MIR) to identify opportunities for quality improvement
• Support and communicate with complaint handling function to ensure trending information is accurate and up to date.
• Provide post-market input and feedback on safety, durability, and reliability design input specifications for Quality report, design reviews, risk analysis, and customer research.
• Support on PSUR
• May support field action related activities i.e., investigations, PFAA, HHEs, etc.
• Familiarity with ISO 13485, 14971, GDP, GMP desired
• Knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics).
• Knowledge of statistical methods and application
• Understanding of US and International Medical Device Regulations
Travel Percentage: None