The Quality Engineer identifies, investigates, plans and conducts activities to improve and assure quality design and manufacturing of medical devices and components. Is responsible to bridge the gap between product engineering, production, supply chain and quality with respect to quality improvements, compliance and cost management.
- Responsible to ensure that the design, and design changes, complies with all specified regulatory agencies. (FDA, ISO, UL, CSA, etc.)
- Daily involvement in making decisions and/or providing technical data for decisions that impact compliance with design specifications.
- Develops, maintains and improves the quality management system to ensure compliance to all specified regulatory agencies.
- Apply problem solving tools/skills to effectively investigate nonconformances down to the root cause(s).
- Participate in the Design Control process (Design Input, Design Output, Reviews, Qualification, Validation, etc.)
- Managing risk analysis through such tools as FMEAs, DOEs, capability analysis, etc.
- Participate in Item Qualification/Commercialization activities from protocol development, to testing, to a completed final report.
- Apply Midmark Production System (MPS) concepts to identify and eliminate non-value added tasks and/or activities in the various areas of responsibility.
- Actively involved in creating documents related to engineering function. Documentation includes, but not limited to, layout drawings, detail drawings, assembly drawings, Bill of Materials, Change Orders, product and component test specifications and design records.
- Actively lead or participate as a member of product research teams to acquire detailed product and user knowledge.
- Design and analyze complex parts and assemblies to applicable specifications. Parts include, but not limited to, Sheet Metal, Plastic Injection Molded, Plastic Vacuum Formed, Aluminum Die cast, Steel Sand cast, and Weldments.
- Perform statistical analysis of all design and development data related to quality design and development; collect, interpret, develop SPC limits and organize results.