About the Role
The Quality Engineer is responsible for supporting all validation and quality engineering activities to support the product life cycle, from development of new products (NPD) from concept through commercialization, through sustaining changes, as part of a cross-functional development team. This includes active participation in origination of design concepts, design specifications, design for quality and manufacturing requirements, process/technology development, product verification/validation, project planning, and applicable documentation. Responsible for all aspects (product and process) related to the quality of the designated product line(s). This includes manufacturability of products, supplier manufacturing, and investigation of customer complaints and deviations. Develops, modifies, applies, and maintains quality standards, and generates protocols and reports. The QE provides coaching to Design Engineers and Manufacturing personnel on Quality System Requirements and process improvement methodologies for their product families., and report directly to the Director of Quality Assurance and Regulatory Affairs. The QE shall have the appropriate training or expertise in general Quality System processes and show a high degree of skill performing the activities. The QE shall complete all assigned task as per 21 CFR part 210, 211, 820 cGMP, ISO 14971 and ISO 13485 requirements and in compliance with the company’s Quality System.
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Requirements
The Quality Engineer is responsible for supporting all validation and quality engineering activities to support the product life cycle, from development of new products (NPD) from concept through commercialization, through sustaining changes, as part of a cross-functional development team. This includes active participation in origination of design concepts, design specifications, design for quality and manufacturing requirements, process/technology development, product verification/validation, project planning, and applicable documentation. Responsible for all aspects (product and process) related to the quality of the designated product line(s). This includes manufacturability of products, supplier manufacturing, and investigation of customer complaints and deviations. Develops, modifies, applies, and maintains quality standards, and generates protocols and reports. The QE provides coaching to Design Engineers and Manufacturing personnel on Quality System Requirements and process improvement methodologies for their product families., and report directly to the Director of Quality Assurance and Regulatory Affairs. The QE shall have the appropriate training or expertise in general Quality System processes and show a high degree of skill performing the activities. The QE shall complete all assigned task as per 21 CFR part 210, 211, 820 cGMP, ISO 14971 and ISO 13485 requirements and in compliance with the company’s Quality System.
About the Company
The Quality Engineer is responsible for supporting all validation and quality engineering activities to support the product life cycle, from development of new products (NPD) from concept through commercialization, through sustaining changes, as part of a cross-functional development team. This includes active participation in origination of design concepts, design specifications, design for quality and manufacturing requirements, process/technology development, product verification/validation, project planning, and applicable documentation. Responsible for all aspects (product and process) related to the quality of the designated product line(s). This includes manufacturability of products, supplier manufacturing, and investigation of customer complaints and deviations. Develops, modifies, applies, and maintains quality standards, and generates protocols and reports. The QE provides coaching to Design Engineers and Manufacturing personnel on Quality System Requirements and process improvement methodologies for their product families., and report directly to the Director of Quality Assurance and Regulatory Affairs. The QE shall have the appropriate training or expertise in general Quality System processes and show a high degree of skill performing the activities. The QE shall complete all assigned task as per 21 CFR part 210, 211, 820 cGMP, ISO 14971 and ISO 13485 requirements and in compliance with the company’s Quality System.