Quality Engineer II
8 months ago
Employment Information
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 disciplines
- Apply statistical techniques and trending to monitor products, processes and controlled work environments to identify potential corrective or preventive actions
- Specify, qualify and monitor equipment used in manufacturing processes, inspection, testing, and controlled work environments
- Perform and document investigations related to products, processes and quality systems
- Review and approve proposed change orders, deviations and nonconforming material records to determine the effect of the changes on materials, products and processes
- Conduct internal quality system audits as assigned
Minimum Qualifications:
- Bachelor’s degree in an Engineering discipline and 5 years’ experience in Quality Engineering
- Experience with Risk Management
- Experience with quality audits, lead auditor certification a plus
- Processing and product evaluation experience and knowledge of QSR and ISO requirements
Preferred Qualifications:
- Previous medical device industry experience
- Experience with ISO 14971
- ASQ and Lean Six Sigma certifications
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 2023 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.
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