Back to jobsApply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Acts as an effective team member in supporting quality disciplines, decisions, and practices
Work within a cross-functional team to identify and implement effective controls and support integration of design control related products, records, and processes
Write various technical documentation for procedure execution, technical rationale, and evidence of the development process.
Support Design Assurance activities as related to Risk Management remediation, Design Control Quality System integration, and other DA related integration priorities
Support Post Market activities, as necessary, of risk based on post-market signals
Actively participate in the Design Change process to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed
Demonstrate good working knowledge and application of validation and statistical techniques in compliance with associated regulatory requirements and internal standards.
Support the verification, validation, and usability testing to meet or exceed internal and external requirements
Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints)
Generate, update, and maintain product risk management tools (e.g., Hazard Analysis, Fault Tree, FMEAs)
Partner with R&D to determine and implement Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.
Partner cross-functionally to identify and support value improvement efforts to support business goals
