Katalyst CRO · 4 hours ago
Supplier Quality Engineer
United States
Contract
Remote
Entry, Mid Level
2+ years expKatalyst CRO is hiring Supplier Quality / Packaging Engineers to ensure compliance with the EU Packaging & Packaging Waste Regulation. This role involves collaboration with suppliers and internal teams to ensure that packaging for EU-bound products meets all regulatory and sustainability requirements.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Design, review, and modify product-specific packaging for global shipment in compliance with regulatory requirements
Compile and maintain product and packaging documentation across multiple business lines
Work directly with suppliers to collect material data, compliance certificates, and declarations
Verify packaging materials contain no restricted substances and meet EU PPWR requirements
Enter and manage documentation in SAP, PLM, and related systems
Organize and support packaging tests (vibration, drop, compression, etc.)
Conduct onsite inspections at manufacturing and supplier locations as needed
Support sustainability and circularity initiatives related to packaging, transport, and logistics
Qualification
Required
Bachelor's degree in engineering (Mechanical, Packaging, Industrial, or related)
Minimum 2-3 years of professional engineering experience (not open to new graduates)
Experience working in a manufacturing environment
Hands-on experience working directly with supplier vendors
Ability to read and interpret engineering drawings
Strong communication skills with the ability to represent independently at supplier sites
Proficiency in Microsoft Office and Adobe products
Willingness to travel up to 25% within the U.S
Experience with packaging engineering (materials, testing, compliance)
Familiarity with EU regulatory requirements such as: EU Packaging & Packaging Waste Regulation (PPWR / Directive 2025/40)
RoHS, FDA, or similar compliance frameworks
Experience with NX, Teamcenter, or other CAD tools (SolidWorks, Creo, Pro/E)
SAP experience within a manufacturing environment
Knowledge of welding symbols or basic welding technologies
Experience with large-scale or industrial packaging (e.g., creating, medical or heavy equipment)
Background in sustainability, circularity, or eco-design related to packaging
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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