The Quality Manufacturing Engineer at Cook Spencer will spend 50% of their time reviewing quality aspects of product lines, including: involvement in CAPA's, supplier quality and manufacturing quality. The remaining 50% will be spent planning, directing and coordinating manufacturing processes for medical device products and supporting Operations to improve existing processes to increase throughput or improve quality.

Performance of risk assessments, internal product and process non-conformances, quality investigations, independent projects and containment activities
Support/asses/develop continual improvement activities in response to non-conformances and other quality data metrics
Review/approve validations, test methods, protocols, monthly non-conformance reports, change requests, risk management files and other documents
Own or assist with internal investigations and CAPA's
Work with Quality Assurance and Production Engineering to verify/validate critical processes/products and apply control mechanisms around those processes/products so they can be effectively monitored
Trending of data and data analysis
Ensure compliance to quality system policies & department procedures
Maintain accurate timely reports and records

**Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) of this employment position.**

Bachelor's degree in Engineering or related technical field; at least 5 years of experience in Quality Engineering, Manufacturing Engineering or Development Engineering
Knowledge of medical device regulations, pertinent standards and guidances
Knowledge of quality tools and principles

Experience in project management and managing multiple activities preferred