What are the responsibilities and job description for the Quality Specialist II position at Laborie Medical Technologies Corp?
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 our Quality team, the Quality Specialist II will play a crucial role in providing support to our Plymouth MN location. The primary focus for the Quality Specialist II will be to support the quality assurance activities including overseeing QMS systems, managing quality processes and records, and contributing to continuous improvement initiatives.
About the Role:
- System administrator for quality management system (eQMS) and oversees and maintains site quality records.
- Owns QMS change control system including executing change controls, maintaining change control files and ensuring all requirements are met, and updating process/procedures to ensure an efficient, effective and compliant system.
- Owns site training program, maintains and delivers QMS training including new hire and annual refreshers, creates and maintains site training files and records and supports training certification program and ensure compliance to process.
- Owns complaint process by evaluating reported issues and makes complaint determination, coordinates internal activities to ensure timely execution and closure and follows up with customer and/or sales to gather additional information.
- Responsible for site equipment calibration program including scheduling and ensuring all out of tolerance results are investigated and documented.
Minimum Qualifications:
- Minimum 5 years' experience with associate's degree, minimum 3 years' experience with a bachelor's degree or 10 years equivalent work experience
- Medical device or regulated industry experience required with knowledge of catheter manufacturing, including balloon or drug coated balloon catheters, strongly preferred
- Experience using electronic systems to administer quality records and proficient in data analysis and reporting tools
- Knowledge of quality systems (ISO 13485, FDA regulations)
- Strong attention to detail and organizational skills with demonstrated ability to lead projects and work independently
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.
