CAPA - Conduct failure investigations, root-cause analysis, and corrective action implementation.
Provides leadership and technical expertise for effective Root Cause Analysis
Provide Quality Engineering support to New Product Development Projects - Support Risk Management activities, lead review and updates to Risk Management File.
ISO 13485, ISO9001
Develop and implement quality improvement with working knowledge of Quality standards and systems.
Some domestic travel mainly within the first year only (up to 20%)
Support Manufacturing Lean initiatives.
Participate/ Lead project teams and attend board meetings.
Education and Experience:
5 years related experience in a regulated environment
B.S in Science or Engineering
Trained Lead Auditor
Background in Medical Device needed
Experience in Supplier Quality desired
Strong oral and written communication skills