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Gurugram, 122001, IN
Job details
Work flexibility: Hybrid
Req ID: R537685
Employee type: Full Time
Job category: Engineering
Travel: 10%
Relocation: No
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Job description
What you will do-
- 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.
- Strong interpersonal skills & communications skills