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Design Assurance Quality Engineer

Company: Titan Medical Inc.
Location: West Columbia
Posted on: June 24, 2022

Job Description:

Position Summary: This individual is responsible for supporting product development and design changes of Titan Medical USA Inc. The Design Assurance Quality Engineer will assist internal and contract design organization(s) and contract manufacturing organization(s) to ensure compliance of their processes and deliverables. Quality Management Responsibilities and Duties: Provide guidance and leadership to organization in the development and maintenance of products. Develop and manage quality related deliverables during product development such as advanced quality plans, standards based testing, etc. Interact with subcontractors for contract design activities where applicable. Work with R&D to develop and manage product risk files including development of product risk plans, risk analyses, failure modes effects analysis (design, product, application, process), etc. Work with R&D to evaluate and catalog applicable technical standards that drive device performance, work with test agencies to establish test requirements, manage agency testing. Develop and document test protocols and summary reports. Work with R&D to develop product specifications including performance, human factors, quality and regulatory related specifications assuring that specifications able to be verified and/or validated. Develop and maintain usability files for products including, as applicable, development of usability protocols, tests and summary reports. Drive the advanced quality planning process including development of written quality plans for products: identification of key component attributes for inspection and/or process control, identification of key suppliers requiring supplier qualifications and audits, support the development of device history records and device master records, and support the overall transfer of products from R&D into manufacturing. Perform supplier audits where applicable and document and maintain supplier files. Responsible to ensure that design control processes are implemented and for constructing and/or auditing the Design History File for designated products. Review and approve product development documentation as the quality representative including design control deliverables, components specifications, bills of materials, and design changes. Attend design reviews and assist as the quality representative. Own and resolve assigned actions. Assist R&D in change management. Assist in the investigation, documentation and review of product complaints. Perform trends analysis of quality system data for management review. Assist in third party audits as applicable. All Other Essential Duties as directed. Education/Experience: Bachelor of Science degree in engineering or other scientific discipline A minimum of 5 years of QA and RA experience including software and hardware design quality. Working knowledge of FDA and EU regulations and associated standards: design controls, design verification and validation, supplier selection and management, risk management/hazard analysis techniques, human factors/usability testing, regulatory approval methods, and overall medical device industry knowledge Prior experience as quality lead on design teams required. Experience in sterilization and biocompatibility testing a plus. Experience in surgical products a plus. Qualifications: Working knowledge of FDA regulations Understanding of the QMS requirements of ISO 13485, ISO 14971, 21 CFR 820 Experience with electro-mechanical device and software validations. Demonstrated ability to contribute to both in-house teams and contract partners. Excellent writing skills; ability to write procedures, work instructions, etc.

Keywords: Titan Medical Inc., Columbia , Design Assurance Quality Engineer, Engineering , West Columbia, South Carolina

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