Design Quality Engineering
Salary undisclosed
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Job Description & Skill Requirement:
10+ years of experience, QMS development and Invitro Diagnostic device experience.
Design and improve quality framework for Design Control to meet ISO 13485 standards with both rigor and flexibility in mind so that it works well for RUO and IVD products.
Lead and manage design control activities for new product development, ensuring compliance with ISO 13485 standards.
Collaborate with cross-functional teams, including R&D, Manufacturing, Quality Control, and Software, to develop and implement robust design control processes.
Provide quality engineering support for reagent and assay development projects, including risk management, design verification, and validation activities.
Develop and maintain design history files (DHF) and other documentation required for potential regulatory submissions and audits.
Conduct design reviews and ensure that design outputs meet design input requirements and customer needs.
Identify and mitigate potential quality and compliance risks throughout the product development lifecycle.
Support the transition of products from development to manufacturing, ensuring that quality requirements are met.
Participate in internal and external audits, providing expertise on design control and product development processes.
Stay current with industry best practices, regulatory requirements, and emerging trends in quality engineering and life sciences.
Lead and manage design control activities for new product development, ensuring compliance with ISO 13485 standards.
Collaborate with cross-functional teams, including R&D, Manufacturing, Quality Control, and Software, to develop and implement robust design control processes.
Provide quality engineering support for reagent and assay development projects, including risk management, design verification, and validation activities.
Develop and maintain design history files (DHF) and other documentation required for potential regulatory submissions and audits.
Conduct design reviews and ensure that design outputs meet design input requirements and customer needs.
Identify and mitigate potential quality and compliance risks throughout the product development lifecycle.
Support the transition of products from development to manufacturing, ensuring that quality requirements are met.
Participate in internal and external audits, providing expertise on design control and product development processes.
Stay current with industry best practices, regulatory requirements, and emerging trends in quality engineering and life sciences.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
Report this job Job Description & Skill Requirement:
10+ years of experience, QMS development and Invitro Diagnostic device experience.
Design and improve quality framework for Design Control to meet ISO 13485 standards with both rigor and flexibility in mind so that it works well for RUO and IVD products.
Lead and manage design control activities for new product development, ensuring compliance with ISO 13485 standards.
Collaborate with cross-functional teams, including R&D, Manufacturing, Quality Control, and Software, to develop and implement robust design control processes.
Provide quality engineering support for reagent and assay development projects, including risk management, design verification, and validation activities.
Develop and maintain design history files (DHF) and other documentation required for potential regulatory submissions and audits.
Conduct design reviews and ensure that design outputs meet design input requirements and customer needs.
Identify and mitigate potential quality and compliance risks throughout the product development lifecycle.
Support the transition of products from development to manufacturing, ensuring that quality requirements are met.
Participate in internal and external audits, providing expertise on design control and product development processes.
Stay current with industry best practices, regulatory requirements, and emerging trends in quality engineering and life sciences.
Lead and manage design control activities for new product development, ensuring compliance with ISO 13485 standards.
Collaborate with cross-functional teams, including R&D, Manufacturing, Quality Control, and Software, to develop and implement robust design control processes.
Provide quality engineering support for reagent and assay development projects, including risk management, design verification, and validation activities.
Develop and maintain design history files (DHF) and other documentation required for potential regulatory submissions and audits.
Conduct design reviews and ensure that design outputs meet design input requirements and customer needs.
Identify and mitigate potential quality and compliance risks throughout the product development lifecycle.
Support the transition of products from development to manufacturing, ensuring that quality requirements are met.
Participate in internal and external audits, providing expertise on design control and product development processes.
Stay current with industry best practices, regulatory requirements, and emerging trends in quality engineering and life sciences.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
Report this job