Quality Engineer
Core
Provide process and quality engineering support on manufacturing lines and to product development teams to ensure delivery and development of highest quality vascular products.
Role type
Quality Engineer (Manufacturing & Product Development)
Builds
Drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters, vessel closure devices, and peripheral stents.
Domain
Healthcare / Medical Devices / Vascular
Required skills
Process/Quality Engineering, Regulatory Compliance (FDA/BSI), CAPA management, Cross-functional collaboration, Project management, Risk management, Data analysis, Operational policy development, Quality system implementation
Preferred skills
CAPA experience, Complex problem analysis, Interpersonal relationship building, Independent work, Cross-functional teamwork, Initiative, Critical thinking, Database usage, Prioritization, Financial system competency
Technologies
Databases, Computer software, Quality tools
Responsibilities
Support project planning and perform assessments and mitigations with cross-functional teams; Provide support to internal and external audits and manage audit findings; Continuously improve processes to align with regulatory and customer requirements; Identify, plan, and conduct medium-size projects requiring risk-managed execution; Lead technical projects involving new methods and system impacts; Serve as a subject matter expert on technical matters; Implement and maintain compliance of the Quality System; Interpret and execute policies affecting work processes; Contribute to the development of operational policies; Evaluate project costs; Identify and implement processes to improve department performance; Ensure sustaining support of the Quality System and regulatory compliance.
Seniority
Mid-level, hands-on IC
