Katalyst CRO
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Supplier Quality Engineer
role at
Katalyst CRO .
Responsibilities:
Manage the complete supplier quality lifecycle, including verification of IQ/OQ/PQ activities.
Review and approve supplier documentation and conduct supplier site visits as required.
Implement and oversee supplier quality processes in compliance with ISO 13485, 21 CFR 820, and related standards.
Conduct supplier-related risk management and generate weekly/monthly project progress dashboards.
Qualifications:
10+ years of proven experience, including 4+ years in medical devices domain and supplier management preferred.
Knowledge of supplier quality activities, ISO 13485, 21 CFR 820, and purchasing controls.
Hands-on experience with IQ/OQ/PQ activities.
Experience reviewing and approving supplier documentation and conducting supplier site visits.
Additional Information:
Seniority level: Mid-Senior level
Employment type: Contract
Job function: Quality Assurance
Industry: Pharmaceutical Manufacturing
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Supplier Quality Engineer
role at
Katalyst CRO .
Responsibilities:
Manage the complete supplier quality lifecycle, including verification of IQ/OQ/PQ activities.
Review and approve supplier documentation and conduct supplier site visits as required.
Implement and oversee supplier quality processes in compliance with ISO 13485, 21 CFR 820, and related standards.
Conduct supplier-related risk management and generate weekly/monthly project progress dashboards.
Qualifications:
10+ years of proven experience, including 4+ years in medical devices domain and supplier management preferred.
Knowledge of supplier quality activities, ISO 13485, 21 CFR 820, and purchasing controls.
Hands-on experience with IQ/OQ/PQ activities.
Experience reviewing and approving supplier documentation and conducting supplier site visits.
Additional Information:
Seniority level: Mid-Senior level
Employment type: Contract
Job function: Quality Assurance
Industry: Pharmaceutical Manufacturing
#J-18808-Ljbffr