Katalyst CRO · 1 day ago
Supplier Quality Engineer
Danvers, MA
Contract
Onsite
Mid LevelKatalyst CRO is a company focused on providing quality services in the CRO industry, and they are seeking a Supplier Quality Engineer. The role involves leading supplier quality initiatives, collaborating with cross-functional teams, and ensuring compliance with medical standards and quality processes.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Process qualification and non-conformance investigations and work independently with limited guidance
Provides team leadership to Supplier Quality through cross-functional collaboration with procurement, quality assurance, engineering, and with suppliers
Supports and sustains robust supplier management programs for designated manufacturing and development activities
Supports department projects and investigations relating to Supplier Quality issues
Review of deliverables and ensure quality and on-time delivery
Adhere project priorities, schedule, and present project status on weekly basis
Responsible to interact with cross-functional teams for protocols, reports, and relevant documents sign-off
Follow clean room procedures and good documentation practices
Responsible for project status reports, participating meetings and suggest improvements
Experience in creation of Forms, Checklists, Work Instruction, Standards, SOP's etc
Excellent knowledge of Medical Standards ISO 13485, ISO 14971 & 21 CFR part 820
Qualification
Required
Process qualification and non-conformance investigations and work independently with limited guidance
Provides team leadership to Supplier Quality through cross-functional collaboration with procurement, quality assurance, engineering, and with suppliers
Supports and sustains robust supplier management programs for designated manufacturing and development activities
Supports department projects and investigations relating to Supplier Quality issues
Review of deliverables and ensure quality and on-time delivery
Adhere project priorities, schedule, and present project status on weekly basis
Responsible to interact with cross-functional teams for protocols, reports, and relevant documents sign-off
Follow clean room procedures and good documentation practices
Responsible for project status reports, participating meetings and suggest improvements
Experience in creation of Forms, Checklists, Work Instruction, Standards, SOP's etc
Excellent knowledge of Medical Standards ISO 13485, ISO 14971 & 21 CFR part 820
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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