Quality Engineer II

About the role

The Quality Engineer II ensures product and process conformity to requirements. They 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 work to resolve audit nonconformities.

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

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)
• ASQ certification preferred
• Leverage Lean Six Sigma training preferred

Qualifications

Commensurate with experience.

Skills

Not specified.

Benefits

See full details in the "Benefits" section of the job listing.

Pay

TBD

Schedule

TBD