In a regulated medical device manufacturing environment the Quality Engineer, Metrology is primarily responsible for the development of new or improved measurement methods used for process validation, process control and product inspection. This would include the programming of a variety of automated inspection systems including video inspection systems, force testing systems, CMM’s and laser scanners. As appropriate other Quality Engineering activities related to quality planning and inspection procedure development and documentation are included in the scope of this position.
Applies a strong knowledge of geometry, metrology and print reading skills to select, develop, and qualify measurement methods and systems for tight tolerance metal and plastic medical device components.
Writes, edits and controls programs for automated inspection equipment such as video measurement systems, and laser scanners.
Develops gauge interface requirements and writes, edits and maintains set-ups for automated data collection software used to collect part measurement data from electronic gauging.
As part of a project team, interacts with customer technical resources and members of RML engineering staff in discussions regarding tolerances, the feasibility of measuring a specified geometry, and alignment of measurement expectations and methods.
Provides input and recommendations to mechanical designers on fixture designs to ensure repeatable part location for critical measurements on certain systems.
Performs measurement system analysis per written procedures in order to qualify measurement methods.
Performs and documents investigations of calibration failures and their impact on product that may have been accepted based on data from the failed equipment.
Writes work instructions or portions of work instructions describing certain measurement processes.
Performs or leads other quality engineering activities such as quality planning, disposition of nonconforming materials or process risk analysis.
Performs training on measurement systems or specific measurement methods for a variety of plant personnel including shop floor employees and QA inspectors.
Specifies or recommends measurement system purchases in order to address new metrology needs or equipment obsolescence.
Owns and manages change and improvement projects and corrective action activities in their area of responsibility.
Acts as a metrology resource to improvement and corrective action teams throughout the organization.
Serves as a resource during internal and third party audits in discussions involving metrology and measurement data.
May supervise 0-4 employees