Quality Engineer II

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

• 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

• 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

Laborie provides equal employment opportunities and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Laborie is committed to providing access and reasonable accommodation in our services, activities, education, and employment for individuals with disabilities.