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Quality Engineer

3.00 to 6.00 Years   Chennai   04 Jun, 2022
West Pharmaceutical Services
Job LocationChennai
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

    Requirements:
    • Must have a third level qualification in Engineering/Quality/Science.
    • Must have 2+ years work experience in a Medical Device manufacturing environment.
    • A working knowledge of quality systems such as ISO 13485 is essential. Experience and knowledge of 21 CFR Part 820 and EU GMP is an advantage.
    • Ideally have an understanding ofplastic process manufacturing.
    • Must have an in-depth knowledge of validations and change control management in a Medical Device environment
    • Must have a working knowledge of statistics, SPC, and ideally the use of Minitab.
    • Must have excellent communication skills both oral and written.
    • Auditing experience to the requirements of ISO 13485 / EU GMP / 21 CFR Part 820 is preferred.
    • Ideally have a working knowledge of Lean / 6 Sigma tools.
    Essential Duties and Responsibilities:
    • Interface on an ongoing basis with customers to ensure requirements / concerns/complaints are communicated and corrective and preventive actions are closed in a timely and effective manner.
    • Management of customer documents into the TGE Quality system ie Drawings; Purchase Specification; Quality Agreements etc. and the training out of relevant personnel.
    • Drafting and approving of quality documentation to meet TGE and Customer requirements ie Quality Specification Sheets (QSS), CAPAs, Defect Library etc.
    • Trending and track of quality data to support quality improvements across the business
    • Lead investigations into material / product issues to ensure a thorough root cause, containment / corrective and preventive action is implemented.
    ,

Keyskills :
inspectionqualityquality controliso

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