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Hire for - Manager - Quality

1.00 to 6.00 Years   Kochi   12 Oct, 2022
KEC International Ltd
Job LocationKochi
EducationNot Mentioned
SalaryNot Disclosed
IndustryOil & Gas / Petroleum
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

    • Develop and standardize production, quality, and customer-service standards in-line with company policies and Global regulatory requirements.
    • Must be well versed in SOP creations and work as per ISO 13485:2016 QMS principals.
    • Identify potential risks before they become a problem, focusing on root cause analysis and handle the CAPA.
    • Handle customer complaints / feedback by analyzing and initiating corrective actions, and communicating the same to Marketing Team.
    • Handle the Design transfer from R&D to Production
    • Author the Medical Devices Risk Management files (RMF) in-line with Global regulatory requirements.
    • Perform internal and external quality audits and compile detailed reports of findings.
    • Must be able to maintain the plant complying with US FDA 21 CFR Part 820, Indian-MDR and EU-MDR requirements and Ready for unannounced audits at any time.
    • Artwork review and approval (in-line with Global regulatory requirements)
    • Batch Record Review, Reconciliation, Approval & Archival
    • Build a strong team through coaching, mentoring, specific training, and performance evaluations.
    ,

Keyskills :
Quality

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