Katalyst Healthcares & Life Sciences Hiring for Quality Engineer at Saint Paul, MN Full Time

• Analyze and maintain post market surveillance information & determine action to reduce complaints/optimize product performance.
• Lead NCEP/CAPA activities in a cross-functional teamwork environment.
• Maintain Risk Management File including Risk Change Analysis, Risk Management Plan/, Hazard Analysis, DFMEA, Task Analysis, and connections to PRA/Supplier Controls.
• Partner with R&D to determine and maintain Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.
• Coordinate the execution and documentation of Design Validation and Verification activities associated with design change.
• Generate Design Verification and Validation protocols and s.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Demonstrate good working knowledge and application of validation and statistical techniques to comply with associated regulatory requirements and internal standards.
• Maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints).

Skills & Qualifications:

• Bachelor’s degree required with at least two years of experience.
• Experience with active product monitoring/complaints.
• Previous design assurance or R&D experience in medical device.
• Quality System Regulations knowledge and ISO 13485, ISO 14971.