Katalyst CRO
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Quality Engineer
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Katalyst CRO . 2 days ago Be among the first 25 applicants. Get AI-powered advice on this job and more exclusive features. Responsibilities
The Quality Engineer is the primary contact for strategic customers regarding customer-driven actions, requests, and Quality Engineering support. Conduct and complete Product Verification Reports (PVR), such as customer PPAPs, for new production introduction (NPI) and customer engineering changes. Investigate product complaints and quality issues using PDCA and 8D methodologies to ensure proper closure in accordance with company and regulatory standards. Maintain the Corrective and Preventative Action (CPAR) process, ensuring effective Root Cause Analysis (RCA) and solutions for internal, external, and regulatory findings. Monitor and ensure timely resolution of Supplier Corrective Action Reports (SCAR). Create and utilize problem logs to identify recurring issues and drive continuous improvement. Manage customer quality action lists, analyzing data to enhance quality for both the company and customers. Implement inspection, testing, and evaluation methods to assess product reliability. Collaborate with Department Managers to maintain, create, and revise QMS documentation to uphold ISO 9001 standards. Work according to deadlines and priorities for delivery and customer requests. Conduct internal audits in compliance with ISO 9001:2015 standards. Support customer compliance requests related to regulations like RoHS and REACH. Participate in MRB meetings and product disposition decisions. Assist in tracking, documenting, and reporting quality metrics to meet organizational goals including CSR, environmental, and health & safety KPIs. Provide cross-functional support for all I Automation facilities as needed. Requirements
Bachelor's degree in engineering (mechanical, chemical, or industrial). At least 5 years of professional experience in Quality Engineering. Strong knowledge of ISO 9001 standards. Experience with CPAR, Root Cause Analysis, and 8D methodologies. Familiarity with QMS documentation and internal audits. Ability to investigate product complaints and prepare Product Verification Reports (PVR). Additional Details
Seniority level: Mid-Senior level Employment type: Contract Job function: Quality Assurance Industry: Pharmaceutical Manufacturing This job is active and accepting applications.
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Quality Engineer
role at
Katalyst CRO . 2 days ago Be among the first 25 applicants. Get AI-powered advice on this job and more exclusive features. Responsibilities
The Quality Engineer is the primary contact for strategic customers regarding customer-driven actions, requests, and Quality Engineering support. Conduct and complete Product Verification Reports (PVR), such as customer PPAPs, for new production introduction (NPI) and customer engineering changes. Investigate product complaints and quality issues using PDCA and 8D methodologies to ensure proper closure in accordance with company and regulatory standards. Maintain the Corrective and Preventative Action (CPAR) process, ensuring effective Root Cause Analysis (RCA) and solutions for internal, external, and regulatory findings. Monitor and ensure timely resolution of Supplier Corrective Action Reports (SCAR). Create and utilize problem logs to identify recurring issues and drive continuous improvement. Manage customer quality action lists, analyzing data to enhance quality for both the company and customers. Implement inspection, testing, and evaluation methods to assess product reliability. Collaborate with Department Managers to maintain, create, and revise QMS documentation to uphold ISO 9001 standards. Work according to deadlines and priorities for delivery and customer requests. Conduct internal audits in compliance with ISO 9001:2015 standards. Support customer compliance requests related to regulations like RoHS and REACH. Participate in MRB meetings and product disposition decisions. Assist in tracking, documenting, and reporting quality metrics to meet organizational goals including CSR, environmental, and health & safety KPIs. Provide cross-functional support for all I Automation facilities as needed. Requirements
Bachelor's degree in engineering (mechanical, chemical, or industrial). At least 5 years of professional experience in Quality Engineering. Strong knowledge of ISO 9001 standards. Experience with CPAR, Root Cause Analysis, and 8D methodologies. Familiarity with QMS documentation and internal audits. Ability to investigate product complaints and prepare Product Verification Reports (PVR). Additional Details
Seniority level: Mid-Senior level Employment type: Contract Job function: Quality Assurance Industry: Pharmaceutical Manufacturing This job is active and accepting applications.
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