Quality Engineer II

4 weeks ago


Westborough, United States Laborie Medical Technologies Corp Full time

We 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're not afraid to roll up our sleeves to make our goals a reality and work together to solve for our customers. We reward and recognize our employees based on our values of Aspire to Greatness, Respect All, Own It, Working Together, Persist with Passion. Who We're Looking For: As a key member of the Quality team, the Quality Engineer II will be responsible for ensuring that the technical regulatory and quality requirements are met for products throughout their product life cycle. About the Role:Provide quality engineering support for quality, manufacturing, design & development, documentation and other product related disciplinesApply statistical techniques and trending to monitor products, processes and controlled work environments to identify potential corrective or preventive actionsSpecify, qualify and monitor equipment used in manufacturing processes, inspection, testing, and controlled work environmentsPerform and document investigations related to products, processes and quality systemsReview and approve proposed change orders, deviations and nonconforming material records to determine the effect of the changes on materials, products and processesConduct internal quality system audits as assignedMinimum Qualifications:Bachelor's degree in an Engineering discipline and 5 years' experience in Quality EngineeringExperience with Risk ManagementExperience with quality audits, lead auditor certification a plusProcessing and product evaluation experience and knowledge of QSR and ISO requirementsPreferred Qualifications:Previous medical device industry experienceExperience with ISO 14971ASQ and Lean Six Sigma certificationsWhy 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 EventsAwarded 2023 Cigna Healthy Workforce Designation Gold LevelLaborie 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.


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