Quality Engineer II

Laborie Medical Technologies Corp•Murray, UT

34d

About The Position

The Quality Engineer II ensures product and process conformity to requirements. Ensuring documentation in conformance to the Quality Management Systems and applicable standards and regulations.

Requirements

At least 5 years Medical Device quality engineering experience
B.S. in engineering or science
Strong knowledge of FDA QSR and ISO 13485 requirements
Critical thinking and sound decision-making skills
Excellent written and verbal communication skills
Ability to independently solve problems, lead projects and influence teams
Demonstrated ability to work as a team player with multi-disciplinary project teams
Demonstrated ability to interpret technical information
Experience with quality audits (lead auditor certification preferred)

Nice To Haves

ASQ certification preferred
Lean Six Sigma training preferred

Responsibilities

Establish and maintain documentation for the inspection and release of raw materials, sub-assemblies and finished medical devices
Perform quality activities in support of Operations, contract manufacturers and R&D
Schedule and document calibration and maintenance activities
Support design and engineering change processes and associated documentation
Support internal and external audit activities and work to resolve audit nonconformities.
Perform and support process, equipment validations.
Investigate, disposition and close nonconformities.
Investigate and close product complaints.
Collect and evaluate quality data for process monitoring, management review and post market surveillance
Perform quality activities related to CAPA processes
Represent Quality Engineering in the development and maintenance of process and product risk assessments (e.g. pFMEAs dFMEA)
Participate in Material Review Board reviews including material segregation, investigation, corrections and dispositions