Ultima Genomics
Senior Design Quality Engineer
Ultima Genomics, Fremont, California, us, 94537
We are looking for a highly motivated
Senior Design Quality Engineer
to join our team! Our Senior Design Quality Engineer plays a strategically important role in ensuring the company’s business success. The primary responsibilities include, but are not limited to, supporting the R&D/Manufacturing Engineering teams and the broader organization by providing strategies for Design Controls, Risk Management and Process/Production Controls. This includes coordination of design transfer and aiding in the implementation of Engineering Change Orders (ECOs), with the goal of ensuring compliance to ISO 13485, ISO 14971 and company requirements. In this role, you will help ensure the quality and reliability of design processes and products, serve as the “voice of Quality” during design/development/NPI activities and collaborate cross-functionally to help resolve design issues across the organization. How You’ll Contribute Assume responsibility for the overall health of the Design Control process Participate in Risk Management activities throughout the product lifecycle Support QMS activities, such as CAPA, Data Analysis, Installation & Servicing and Compliant Handling Provide clarification and guidance to teams on Design Control requirements Ensure effective verification and validation of design specifications and requirements Ensure accuracy and completeness of Design History Files Collaborate with Operations and R&D on product improvement plans. Represent the ‘Design for Quality’ and ‘Design for Reliability’ perspectives in engineering design reviews Act as the subject matter expert on Design Control Support the Quality Management System as required Help develop and implement Design Control processes to ensure compliance with internal and external requirements Provide input to design and manufacturing engineering project DHF deliverables including material specifications, drawings, inspection procedures, and manufacturing procedures to ensure that the resulting products can be adequately manufactured and tested Other duties as assigned Qualifications, Skills, Knowledge & Abilities BS in Engineering with 7 years of related experience or equivalent combination of education and experience in life science sector is desired Working knowledge and practical application of ISO 13485 and ISO 14971 requirements Working knowledge of hardware, software and chemistry development lifecycle methodologies is highly desired Process validation (IQ/OQ/PQ) experience highly desired Must possess strong analytical and problem-solving skills, as well as excellent written and verbal communication skills Ability to manage priorities in a fast-paced environment
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Senior Design Quality Engineer
to join our team! Our Senior Design Quality Engineer plays a strategically important role in ensuring the company’s business success. The primary responsibilities include, but are not limited to, supporting the R&D/Manufacturing Engineering teams and the broader organization by providing strategies for Design Controls, Risk Management and Process/Production Controls. This includes coordination of design transfer and aiding in the implementation of Engineering Change Orders (ECOs), with the goal of ensuring compliance to ISO 13485, ISO 14971 and company requirements. In this role, you will help ensure the quality and reliability of design processes and products, serve as the “voice of Quality” during design/development/NPI activities and collaborate cross-functionally to help resolve design issues across the organization. How You’ll Contribute Assume responsibility for the overall health of the Design Control process Participate in Risk Management activities throughout the product lifecycle Support QMS activities, such as CAPA, Data Analysis, Installation & Servicing and Compliant Handling Provide clarification and guidance to teams on Design Control requirements Ensure effective verification and validation of design specifications and requirements Ensure accuracy and completeness of Design History Files Collaborate with Operations and R&D on product improvement plans. Represent the ‘Design for Quality’ and ‘Design for Reliability’ perspectives in engineering design reviews Act as the subject matter expert on Design Control Support the Quality Management System as required Help develop and implement Design Control processes to ensure compliance with internal and external requirements Provide input to design and manufacturing engineering project DHF deliverables including material specifications, drawings, inspection procedures, and manufacturing procedures to ensure that the resulting products can be adequately manufactured and tested Other duties as assigned Qualifications, Skills, Knowledge & Abilities BS in Engineering with 7 years of related experience or equivalent combination of education and experience in life science sector is desired Working knowledge and practical application of ISO 13485 and ISO 14971 requirements Working knowledge of hardware, software and chemistry development lifecycle methodologies is highly desired Process validation (IQ/OQ/PQ) experience highly desired Must possess strong analytical and problem-solving skills, as well as excellent written and verbal communication skills Ability to manage priorities in a fast-paced environment
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