Quality Engineer II

We believe that great healthcare is an essential safeguard of human dignity. A t 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 our Quality team, the Quality Engineer II will play a crucial role in providing support to our Orangeburg NY location. The primary focus for the Quality Engineer II will be to lead quality assurance initiatives, ensuring that processes, products, and systems comply with regulatory and company standards. The Quality Engineer II serves as a technical resource for cross-functional teams. About the

Role:

Perform quality activities in support of Operations, R D and contract manufacturers. Support design and engineering change processes and associated documentation and internal and external audit activities and work to resolve audit nonconformities. Perform quality activities related to CAPA process. Represent Quality Engineering in the development and maintenance of process and product risk assessments (i.e., FMEAs). Participate in Material Review Board reviews including material segregation, investigation, corrections, and dispositions.

Minimum Qualifications:

Bachelor's degree in an Engineering discipline with minimum 5 years' experience in Quality Engineering Medical device or regulated industry experience required Experience with Risk Management (ISO 14971 preferred) Experience with quality audits (lead auditor certification preferred) Strong attention to detail and organizational skills with demonstrated ability to lead projects and work independently ASQ certification and Lean Six Sigma training preferred

Why 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 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 Awarded 2024 Cigna Healthy Workforce Designation Gold Level 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.