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Production Design Assurance Engineer - Minneapolis, United States - ComTec Information Systems (IT)
Description
Title:
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 development, transfer and sustaining initiatives for the Peripheral Vascular business of Image Guided Therapy Devices.
You will have the opportunity to work in a team environment to efficiently maintain quality standards and meet our customer demands.
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 processes and global standards.
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.
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 Quality policies.
Review items thru Solidworks and be comfortable reviewing these details.
Assist in simplifying part number changes by creating a smart sheet that allows these changes to be made easier.
Requirements
BS in Engineering, Sciences, or a related field.
4+ years experience in Quality Assurance, Design Engineering, Systems Engineering, or similar in a regulated industry
Medical Device Experience Is Required
Solidworks and Windchill experience required
Experience with ISO 14971, 21 CR 820, ISO 13485, EU MDR, IEC , 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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