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

Requisition ID2024-14240

Posting Date2 weeks ago(5/16/2024 10:30 AM)

Job Location(s) Spencer IN United States

Travel Less than 10%

Position Type Full Time

Company Cook Inc - Spencer

Category Quality