As a Staff Quality Engineer, Design Assurance you will lead risk management processes and design control activities for product sustenance.
Independently Lead as DAE SME on the projects.
Define project scope and resource needs for projects and lead larger departmental initiatives
Working effectively with respective cross functional stakeholders in product sustenance and assessing health risk and influence team members and project teams as SME.
Owing risk management and usability deliverables as per ISO 14971 and IEC 62366-1 respectively.
Identify project obstacles, develop solutions and present to project team
Experience in risk management activities in product sustenance teams by developing risk management plans and reports, conducting risk reviews, verifying implementation and effectiveness of risk controls.
Driving Critical Quality Attribute (CQA) assessment due to changes in manufacturing process and risk assessment impact of the changes.
What you will need-
Good understanding of verification and validation activities with a rigor to drive design philosophy.
Good understanding of data analysis and statistical techniques to drive appropriate risk management activities and prioritization of issues and manufacturing processes.
Minimum of 6+ years’ experience in risk management, testing and analysis ideally in a strongly regulated environment such as medical device, military or aerospace industry
BE/BTech/ME/MTech in Mechanical Engineering or related field from premier institutes
Participation in design reviews by identifying risks associated with the product use and tracking how the design, documentation, and manufacturing process mitigate those issues throughout the development process.
Influential partnership with R&D to drive safety and performance during change.
Effective communication and previous experience in implementing compliance regulations and standards, including 21CFR820, ISO 13485, ISO 14971 throughout the design and development process.
