Quality Manufacturing Engineer
Cook Biotech
Spencer, IN
Overview
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.
Responsibilities
• 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.**
Qualifications
• 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
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