Quality Engineer II

Quality Engineer IIWe believe that great healthcare is an essential safeguard of human dignity. At Laborie, we know the work we do matters – it's what fuels our motivation and contributes to our success. If you're ready to make a positive impact in the lives of patients across the globe, we'd like to meet you. We support and empower our employees to grow their careers in an environment that encourages a sense of belonging and a connection to doing good. We reward and recognize our employees based on our values of Aspire to Greatness, Respect All, Own It, Working Together, Persist with Passion.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.About the Role:Establish and maintain documentation for the inspection and release of raw materials, sub-assemblies and finished medical devicesPerform quality activities in support of Operations, contract manufacturers and R&DSchedule and document calibration and maintenance activitiesSupport design and engineering change processes and associated documentationSupport 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 surveillancePerform quality activities related to CAPA processesRepresent 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 dispositionsMinimum Qualifications:At least 5 years engineering experience in a regulated fieldB.S. in engineering or scienceStrong knowledge of FDA QSR and ISO 13485 requirementsCritical thinking and sound decision-making skillsExcellent written and verbal communication skillsAbility to independently solve problems, lead projects and influence teamsDemonstrated ability to work as a team player with multi-disciplinary project teamsDemonstrated ability to interpret technical informationExperience with quality audits (lead auditor certification preferred)ASQ certification preferredLean Six Sigma training preferredWhy Laborie: Our Mission every day is to operate as a world-class specialist medical company making and advancing technologies that preserve and restore human dignity. We do that today by helping people with pelvic and gastrointestinal conditions live normal lives, and by helping mothers and babies have safe deliveries.Paid time off and paid volunteer timeMedical, Dental, Vision and Flexible Spending AccountHealth Savings Account with Company Funded Contributions401k Retirement Plan with Company MatchParental Leave and Adoption ServicesHealth and Wellness Programs and EventsLaborie 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.