We are looking for a driven and detail-oriented individual that has a passion for Quality in Product Sustenance. We need you to be an advocate for sustain quality into our designs. You will be joining a team of self-motivated, independent and creative thinkers, we work together and across function ensuring product excellence. Our team works within the Design Assurance function, but your role will have significant interaction with PD, Marketing, Regulatory and Operations.
Responsibilities-
As a Senior Quality Engineer, Design Assurance you will lead risk management processes and design control activities for product sustenance. Being a part of this team means that you are working cross functionally to drive our company’s mission and strengthen the brand. You should love solving novel problems in fast paced and stimulating environment.
Working effectively with respective cross functional stakeholders in product sustenance and assessing health risk.
Owing risk management and usability deliverables as per ISO 14971 and IEC 62366-1 respectively.
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.
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.
Good understanding of manufacturing processes.
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
Professional Requirements
Minimum of 5+ years’ experience in risk management, testing and analysis ideally in a strongly regulated environment such as medical device, military or aerospace industry
Location:
Gurugram, Haryana
