What are the responsibilities and job description for the Manufacturing Quality Engineer 1 position at Lensa?
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Overview
The Quality Manufacturing Engineer at Cook Incwill spend 50% of their time reviewing quality aspects of product lines, including: involvement in CAPA's, supplier quality and manufacturing The Quality Engineer serves as the lead quality representative of certain product lines within product development, manufacturing, post-market surveillance, and/or CAPA.
Responsibilities
Posting Date2 weeks ago(3/12/2025 2:05 PM)
Job Location(s)Bloomington IN United States
Job LocationsUS-IN-Bloomington
TravelLess than 10%
Position TypeFull Time
CompanyCook Inc - Bloomington
CategoryQuality
Overview
The Quality Manufacturing Engineer at Cook Incwill spend 50% of their time reviewing quality aspects of product lines, including: involvement in CAPA's, supplier quality and manufacturing The Quality Engineer serves as the lead quality representative of certain product lines within product development, manufacturing, post-market surveillance, and/or CAPA.
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
Posting Date2 weeks ago(3/12/2025 2:05 PM)
Job Location(s)Bloomington IN United States
Job LocationsUS-IN-Bloomington
TravelLess than 10%
Position TypeFull Time
CompanyCook Inc - Bloomington
CategoryQuality
