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Quality Assurance Engineer
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Quality Assurance Engineer
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Quality Assurance Engineer
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Quality Assurance Engineer
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Principal Design Assurance Engineer
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Senior Design Assurance Engineer
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Cypress HCM Minneapolis, United StatesThis Quality Design Assurance Engineer role will focus on design assurance supporting product and process development to ensure a successful production launch and delivery of the highest quality product to the customer. This position also supports design change and other quality ...
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Sr. Design Assurance Engineer
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Senior Engineer, Quality Assurance
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Senior Engineer, Quality Assurance
6 days ago
Padagis LLC Minneapolis, United StatesPadagis LLC is seeking a Senior/Lead Quality Assurance Engineer to provide primary Quality Assurance review and approval for annual product reviews, deviations, and other cGMP documentation and studies conducted at PMN, ensuring that all information and documentation conforms to ...
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Senior Design Assurance Engineer
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Cypress HCM Minneapolis, United StatesThis Quality Design Assurance Engineer role will focus on design assurance supporting product and process development to ensure a successful production launch and delivery of the highest quality product to the customer. This position also supports design change and other quality ...
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Production Design Assurance Engineer
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ComTec Information Systems (IT) Minneapolis, United StatesTitle: Design Assurance Engineer /QA Engineer Consultant · Duration: 12 Months · Location: Plymouth, MN · Hybrid schedule of 3 days onsite and 2 remote. · Job Description · The Design Assurance Engineer will support design controls and quality management associated with the ...
Design Assurance Engineer - Saint Paul, United States - Ativa Medical Corporation
Description
Job Description
Job DescriptionDesign Assurance engineer to represent the Quality function on a product development team. This engineer would be a key contributor to risk management and design verification planning and execution. Secondarily, this position would also provide support for supplier management and material quality activities.
Essential Job Duties & Skills:
· Work with the product development team(s) in conducting risk analysis activities such as Design FMEAs, Process FMEAs, Hazard Analysis, and User Risk Analysis.
· Manage tracability of design requirements through risk mitigation and design verification
· Technical writing and critical review of design verification plans, procedures, test protocols and reports.
· Critical review of design and process documents and records such as procedures, specifications, drawings and various Design History File records
· Lead key equipment qualification efforts
· Lead supplier management activities
· Review and evaluate non-conforming materials.
· Work with vendors to correct material non-conformances
· Generate inspection procedures for both incoming parts and on-site production.
· Review manufacturing documentation for accuracy and clarity.
· Contribute to process validation activities
· Proficient knowledge and use of applicable industry standards specifically, ISO 13485 for Quality Systems, and ISO 14971 for Risk Management
· Proficient in MS Office Suite including but not limited to MS Outlook, MS Word MS Excel, MS PowerPoint.
Additional Job Expectations:
· Being aligned with team goals and supportive in a team environment
· Sound communication in collaborations with other company functions (written and verbal)
· Using good judgment when confronted with choices
· Being organized, thorough in prioritizing and generating work products
· Being both proactive and professional
Education and Experience:
· BS in Mechanical Engineering or a related field
· 5+ years of Design Assurance in Life Sciences Industry
IVD medical device environment a plus
· Experience with statistical methods and terminology
· Demonstrated structured problem-solving skills