Katalyst CRO · 2 months ago
Supplier Quality Engineer
Indianapolis, IN
Contract
Hybrid
Mid LevelKatalyst CRO is looking for a Supplier Quality Engineer to serve as a liaison between suppliers and customer plant sourcing. The role involves managing supplier quality issues, conducting audits, and supporting the plant Quality Manager in monitoring supplier product quality and performance.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
This position will work as an interface between the supplier and Customer plant sourcing, supplier quality and inspection areas
Conduct PPAP planning with Suppliers as per CQP
Follow up, expedition to meet development timelines
Work Closely all Product Deviation notice and work for resolutions
Supplier Corrective Action & Preventive Action (CAPA) management
Supplier Process audit and report documentation if required
Support for alternate supplier identification, qualification
Facilitate escalation of unresolved supplier quality issues within assigned projects and suppliers
First Article Inspection (FAI) at supplier facility / remotely as per Customer guidelines
Support the plant Quality Manager to monitor and report on supplier product quality and performance
Report on Key Performance Indicators (KPIs)
Recommendations for areas of supplier focus
Generally, Sheetmetal, machined, Plastics, Rubber, Electrical / Electro-mechanical components
Qualification
Required
This position will work as an interface between the supplier and Customer plant sourcing, supplier quality and inspection areas
Conduct PPAP planning with Suppliers as per CQP
Follow up, expedition to meet development timelines
Work Closely all Product Deviation notice and work for resolutions
Supplier Corrective Action & Preventive Action (CAPA) management
Supplier Process audit and report documentation if required
Support for alternate supplier identification, qualification
Facilitate escalation of unresolved supplier quality issues within assigned projects and suppliers
First Article Inspection (FAI) at supplier facility / remotely as per Customer guidelines
Support the plant Quality Manager to monitor and report on supplier product quality and performance
Report on Key Performance Indicators (KPIs)
Recommendations for areas of supplier focus
Generally, Sheetmetal, machined, Plastics, Rubber, Electrical / Electro-mechanical components
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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