Quality Engineer II
Laborie · Salt Lake City, UT · 2 wk ago
On-siteQuality AssuranceFull-time
About the Role
- 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
Qualifications
- 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
- Lean Six Sigma training preferred
Benefits
- Paid time off and paid volunteer time
- Medical, Dental, Vision and Flexible Spending Account
- Health Savings Account with Company Funded Contributions
- 401k Retirement Plan with Company Match
- Parental Leave and Adoption Services
- Health and Wellness Programs and Events