manufacturing engineer Spencer, IN
Cook Medical Inc
Full Time
Spencer, IN
88150 - 65980 USD ANNUAL Today
Job description
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
- 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
Cook Medical Inc
www.cookmedical.com
Bloomington, IN
Carl Cook
$1 to $5 billion (USD)
10000+ Employees
Company - Private
Health Care Products Manufacturing
1963
