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Senior Supplier Quality Engineer

2.00 to 5.00 Years   Bangalore   20 Oct, 2022
West Pharmaceutical Services
Job LocationBangalore
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

    • 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:
    • Functional lead for Supplier approval process in accordance with supplier management process.
    • Reporting area of responsibility metrics.
    • Provide quality inputs to supplier scorecards / management review.
    • Coordinate quality documentation required for determination of critical suppliers, this will involve obtaining input from the engineering team and suppliers for each new component sourced.
    • Liaise with suppliers to obtain supplier approval documents.
    • Maintain relevant documentation to comply with quality standards and customer requirements.
    • Oversight upkeep of supplier files to include supplier qualification documentation, supplier monitoring documentation/links, up to date supplier certificates.
    • Interact with suppliers to resolve quality issues through the NC/SCAR process and lead quality improvement initiatives with suppliers / customers
    • Manage the return of samples and lots to suppliers as necessary.
    ,

Keyskills :
spcppapquality controlinspection

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