Quality Manufacturing Engineer

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