Katalyst CRO ยท 2 months ago
Engineer Quality I - Supplier Quality
Horicon, WI
Contract
Onsite
Entry Level
2+ years expKatalyst CRO is seeking a highly motivated PDP / Supplier Quality Engineer to lead quality planning activities for product development programs and continuous improvement initiatives. The role involves collaboration with cross-functional teams to ensure supplier quality and product excellence.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Lead and participate in cross-functional quality activities, including
DPARs (Design/Product Problem Analysis Reports)
FMEA (Failure Modes & Effects Analysis)
Control plans, design reviews, supplier audits, risk assessments, and root cause analysis
Identify, communicate, and resolve supplier quality issues for PDP programs and production
Facilitate corrective actions using the 8D process
Manage Return Goods Authorizations (RGAs), Supplier Change Requests (SCRs), and supplier improvement initiatives
Collaborate with internal teams to support continuous improvement (CI) and value improvement (VI) projects
Qualification
Required
Bachelor's degree in engineering or technology-related field, or equivalent experience
2+ years of experience in manufacturing, quality engineering, or supply management (recent graduates considered)
Hands-on experience with quality tools: FMEA, NCCA, SPC, Root Cause Analysis, 8D, Six Sigma
Experience with statistical analysis and problem-solving
Ability to read and interpret drawings, schematics, product models, and GD&T
Strong communication, facilitation, and organizational skills
Ability to lead and prioritize tasks independently
Supplier audits, DPARs, and design reviews experience
Knowledge of SAP-PAG and SAP-PDM
Audit experience: Process Verification Audits, Special Process Audits
Experience with Lean manufacturing
Familiarity with riding lawn equipment or utility vehicle production processes
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
Company data provided by crunchbase