US Tech Solutions
QA Engineer Consultant II
US Tech Solutions, Minneapolis, Minnesota, United States, 55400
Summary:Medical Device experience is required. This person will be reviewing items through SolidWorks, so they need to have experience and be comfortable reviewing these details. This person will be assisting in simplifying part number changes by creating a smart sheet that allows these changes to be made easier. Windchill experience is highly desired.
Roles & Responsibilities:The Design Assurance Engineer will support design controls and quality management associated with the development, transfer and sustaining initiatives for the Peripheral Vascular business of Image Guided Therapy Devices. Products include Class III non-implantable and implantable medical devices including drug combination devices. You will have the opportunity to work in a team environment to efficiently maintain quality standards and meet our customer demands. You are responsible for:Lead all quality elements of Design Controls and product DHF for design projects.Drive Quality norms associated with design engineering projects.Support integration of Risk Management processes throughout the product lifecycle from initial development through post market surveillance in accordance with product processes and global standards.Lead Quality Plan initiatives associated with Risk Management and Quality System integration.Support integration of post market surveillance processes into Design Controls and Sustaining initiatives through analysis of field performance, identification of trends and risks, and actions to eliminate or mitigate adverse post market issues.Support the Regulatory Affairs department for submissions and respond to submission questions.Lead and support Corrective and Preventive Actions (CAPA) and QMS continuous improvement initiatives.Analyze situations/data using engineering principles and collaboration to identify gaps between project work and QMS.Quality responsibility for transfer of new products and sustaining projects to manufacturing and operations quality and supplier quality teams.Support internal and external audits.Acts in full compliance to all applicable regulatory requirements and Product Quality policies.
Qualifications/Skills:BS in Engineering, Sciences, or a related field.• 4+ years’ experience in Quality Assurance, Design Engineering, Systems Engineering, or similar in a regulated industry.• Experience with ISO 14971, 21 CR 820, ISO 13485, EU MDR, IEC 60601-1, IEC 62366, and IEC 62304 standards.• Strong understanding of design quality tools, methods, and activities.• Strong statistical background in verification, validation, hypothesis testing, sampling, multifactor analyses and measurement system analysis.• Demonstrated expertise in managing complex projects.• Excellent customer service and interpersonal communication skills, experience leading presentations in front of peers and managers.• Hands-on problem solver that drives solutions within teams.• Excellent teamwork skills including influencing and building rapport with internal customers and stakeholders.• Demonstrated track record of completing projects on-time that meet all objectives.• Local candidates are preferred. Relocation assistance available.
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Roles & Responsibilities:The Design Assurance Engineer will support design controls and quality management associated with the development, transfer and sustaining initiatives for the Peripheral Vascular business of Image Guided Therapy Devices. Products include Class III non-implantable and implantable medical devices including drug combination devices. You will have the opportunity to work in a team environment to efficiently maintain quality standards and meet our customer demands. You are responsible for:Lead all quality elements of Design Controls and product DHF for design projects.Drive Quality norms associated with design engineering projects.Support integration of Risk Management processes throughout the product lifecycle from initial development through post market surveillance in accordance with product processes and global standards.Lead Quality Plan initiatives associated with Risk Management and Quality System integration.Support integration of post market surveillance processes into Design Controls and Sustaining initiatives through analysis of field performance, identification of trends and risks, and actions to eliminate or mitigate adverse post market issues.Support the Regulatory Affairs department for submissions and respond to submission questions.Lead and support Corrective and Preventive Actions (CAPA) and QMS continuous improvement initiatives.Analyze situations/data using engineering principles and collaboration to identify gaps between project work and QMS.Quality responsibility for transfer of new products and sustaining projects to manufacturing and operations quality and supplier quality teams.Support internal and external audits.Acts in full compliance to all applicable regulatory requirements and Product Quality policies.
Qualifications/Skills:BS in Engineering, Sciences, or a related field.• 4+ years’ experience in Quality Assurance, Design Engineering, Systems Engineering, or similar in a regulated industry.• Experience with ISO 14971, 21 CR 820, ISO 13485, EU MDR, IEC 60601-1, IEC 62366, and IEC 62304 standards.• Strong understanding of design quality tools, methods, and activities.• Strong statistical background in verification, validation, hypothesis testing, sampling, multifactor analyses and measurement system analysis.• Demonstrated expertise in managing complex projects.• Excellent customer service and interpersonal communication skills, experience leading presentations in front of peers and managers.• Hands-on problem solver that drives solutions within teams.• Excellent teamwork skills including influencing and building rapport with internal customers and stakeholders.• Demonstrated track record of completing projects on-time that meet all objectives.• Local candidates are preferred. Relocation assistance available.
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