Quality Engineer II
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 is responsible for ensuring that the technical regulatory and quality requirements are met for products throughout their product life cycle. This role focuses on quality system maintenance, process improvements, and supporting production operations.
About the Role:
- Develop and execute quality plans and protocols for product and process validations.
- Conduct root cause analysis and implement corrective and preventative actions (CAPA) and participates in projects/CAPA teams of moderate complexity.
- Review and approve change control requests to ensure compliance, support supplier qualification activities and monitor supplier performance, and support risk management.
- Perform risk assessments, including Failure Modes and Effects Analysis (FMEA), participate in internal and external audits, and collaborate with cross-functional teams on product development and process improvements.
- Develop simple to moderate protocols, procedural updates, identifies inspection process improvements.
- 2+ years' experience in Quality Engineering with technical bachelor's degree or equivalent work experience
- Previous medical device industry experience preferred
- Knowledge of quality tools and methodologies (Six Sigma, SPC, etc.)
- Familiarity with quality standards and regulations (ISO 13485, FDA 21, CFR Part 820)
- Proficiency in data analysis and statistical tools
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
- 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.