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Senior R&D Quality Engineer

5.00 to 8.00 Years   Mumbai City   18 Mar, 2022
Perkin Elmer India
Job LocationMumbai City
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

    Job Title Senior R&D Quality Engineer Location(s) MumbaiPerkinElmer Inc., is looking to hire a Senior R&D Quality Engineer to join its Quality Regulatory and Medical team. The candidate will be a part of a team that provides focused quality engineering support for new product development, design changes and sustaining engineering. They will help develop, establish and maintain quality engineering methodologies, systems, and practices which meet PKI, customer, and regulatory requirements. They should be knowledgeable in design and process control for product development and have experience in optimization and validation of test methods and inspection procedures.
    • Participate in development teams to support the new product design, design changes, material testing, specification preparation, qualification, report preparation, process/text documentation and commercialization of products.
    • Coordinates and supports testing and experiments to include validation planning and execution.
    • Assists performing troubleshooting on products/process problems as related to design, material or process.
    • Summarizes, analyzes, and draws conclusions from test results to access risk.
    • Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
    • Assures the development and execution of streamlined business systems which effectively identify and resolve quality issues
    • Implement QA measures, test plans and test specifications for R&D projects.
    • Acts as an effective team member in supporting quality disciplines, decisions, and practices.
    Job Requirements
    • Bachelors degree in Engineering, Medical Technology, or related field.
    • 5-8 years of experience working in R&D or Quality.
    • Previous experience with 21CFR820, ISO13485, ISO14971
    Preferred Requirements
    • Knowledge of industry practices and working knowledge of Medical Device regulations, a plus
    • General knowledge and application of technical and business concepts, procedures and practices
    • Strong problem-solving skills
    • Collaborates effectively in a team environment
    • Able to influence decision of others
    ,

Keyskills :
inspectionqualityquality controlisocalibrationnew product designnew product developmentiso 13485music makingproduct designproblem solvingprocess controlmaterial testingbusiness systems

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