ID
#12269494
Job type
Contract
Salary
Depends on Experience
Source
BDM, Saibber LLC
Date
2021-04-13
Deadline
2021-06-12

Risk Management Consultant

Massachusetts, Boston, 02108

Contract

Vacancy expired!

Dear Candidate,Greeting of the day.This is “Prakhar Shukla” from “Saibber LLC”.We are looking for

Risk Management Consultant in BOSTON, MA. Kindly go through the job description given below and reply me your resume at# or call Role: Risk Management ConsultantLocation: BOSTON, MADuration: 6-12 Months

Required Skills:-

Risk Management ISO 14971, ISO 13485, and MDD/MDR , Verification + Jira, Jama tool experience. Medical device. Robotics, FMEA

Key Responsibilities Actively participates in requirement analysis phase and suggest changes or create documentation defects for needed clarity in the requirements for testability.Review test design , test cases for requirement cove rage and adequacy of test scenarios. Suggest changes to test scenarios or test paths as needed.Ensure review mechanisms and project activities are in compliance to procedure or SOP’ set or defined by the client.Work with test development team in identifying the

SOUP known anomalies list, search strategy, review assessments’ for their applicability to the product.Support SOUP qualification activity including authoring, updating or reviewing relevant items as needed from time to time.Actively participate in all client meetings to discuss blocker, concerns for test development. Flag issues to the quality manager (as needed).

Desired Skills and ExperienceExperience working in a regulated industry

(e.g., FDA-regulated or ISO13485).Experience in reviewing

verification/validation

test plan development and root cause failure analysis.Hands on experience in tools such as

JIRA ( for defect/test status management), JAMA ( requirement/test development management) or similar software tools Experience in Risk Management ISO 14971, sFMEA ActiviesWorking knowledge of

ISO 13485, ISO 14971, 21 CFR 820, IEC 62304, IEC 60601-1 and MDD/MDR.Demonstrated ability to ramp-up quickly , flexibility in adapting to changing project scopes or deliverables is a plus.Must have good verbal and written communication skills.

Vacancy expired!

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