Quality Engineer

Katalyst CRO is a company focused on quality engineering solutions, and they are seeking a Quality Engineer to enhance their team. The role involves reviewing candidates, ensuring technical depth in risk management and verification & validation, and participating in integration and remediation efforts.

Responsibilities:

• The manager is seeking a new batch of candidates to review. Highlighted below is where some of the individuals from the first round of interviews fell short
• Technical depth in TMV, risk management and V&V. (Seeking experience both developing and executing the activities, not just being part of a team)
• Experience being part of integration efforts and/or major remediation efforts Some of the candidates, they spoke about TMV but they couldn't get into the technical depth so we are looking for those who have more experience

Requirements:

• Bachelors in Engineering or related
• 4+ years of experience
• Experience in NPD or Design Quality (21 CFR 820)
• Experience with design integration/DHF remediation
• Design integration, design remediation, implementation of DFM principles and supporting risk management architecture
• Experience with vascular devices (catheters, stents, guidewires etc.) is a huge plus