The Operations Quality Engineer (QE) plays an important role in the development and manufacture of Velano Vascular’s medical technology. The Operations QE is a member of the Operations Quality team who provides support primarily following design transfer of the product, i.e., starting with process and production controls through decommission. The Operations QE adheres to Velano Vascular Quality System, recognized Quality System Regulations and international standards, such as 21 CFR 820, ISO 13485, ISO 14971, and EU MDD/MDR. He/she must also foster cross functional relationships to ensure operational and quality requirements are met throughout the business.
With oversight and general guidance from Quality Management, the QE provides engineering direction that improves product quality within the manufacturing space. The Operations Quality Engineer has responsibility for a range of critical Quality and Operations activities, including but not limited to:
- Process controls and validation
- Test Method development and Test Method Validation
- Risk management activities (e.g., FMEA/FTA)
- In-process inspections
- Lot history records review and Sterile Lot Release
- Build scheduling and forecasting
- Purchasing, inventory management and controls
- Non-Conformance, Complaint, and CAPA Investigation
- Engineering project management
- Interface with regulatory bodies.
- Other responsibilities, as assigned.
- 1 - 3 years working in the medical device field, preferably in an Operations or Quality role.
- Technical ability in various processes, such as tolerance analyses, Gage R&R, statistical process controls
- Technical writing ability, e.g., Test Protocols and Reports.
- Preferred candidate has experience in electronic data management systems, such as Enterprise Resource Planning tools / software.
- Strong team orientation and collaboration ability to work independently.
- Organized and effective time management skills.
- Strong interpersonal and communication skills.
- Ability to manage deadlines.
- Embodies the Velano Vascular IMPACT core values and is a model of integrity.
- Bachelor of Science degree in a technical discipline (mathematics, statistics, sciences, engineering) is required. Master’s Degree and/or certification to a recognized quality or regulatory organization, e.g., ASQ CQE, is preferred.