Katalyst CRO · 1 day ago
Supplier Quality Engineering
Indianola, PA
Full-time
Onsite
Mid, Senior Level
4+ years expKatalyst CRO is a Confidential company seeking a Supplier Quality Engineer to lead supplier qualification activities for new components and processes. The role involves planning, executing, and documenting qualifications while partnering closely with R&D teams to ensure alignment with design intent.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Leading supplier qualification activities for new components and processes
Planning, executing, and documenting IQ/OQ/PQ and component/process qualifications
Reviewing supplier documentation such as FAIs, pFMEAs, Control Plans, Process Flow Diagrams
Evaluating process capability (Cpk) and performing statistical analysis
Partnering closely with Mechanical/Electrical R&D teams to ensure alignment with design intent
Acting as the quality interface between R&D and selected suppliers
Qualification
Required
Bachelor's degree in engineering or a related technical field
4–7 years of quality experience in a regulated industry (medical devices strongly preferred)
Hands‐on knowledge of IQ/OQ/PQ, FMEAs, Control Plans, Cpk, Gage R&R, MSAs, FAIs
Ability to interpret engineering drawings and technical specifications
Strong communication skills, especially in supplier‐facing environments
Preferred
Experience with injection molding, PCB manufacturing/assembly, machining, or casting
Familiarity with ISO 13485 or ISO 9001
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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