Katalyst CRO · 1 day ago
Supplier Quality Engineer
Warsaw, IN
Contract
Onsite
Senior Level
5+ years expKatalyst CRO is seeking a Senior Supplier Quality Engineer to join their Supplier Quality Engineering team as a consultant. The role focuses on supporting external manufacturing suppliers in the Medical Devices / Orthopedics domain, ensuring compliance with quality and regulatory standards while managing supplier quality assurance activities.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Lead supplier quality assurance activities for external manufacturing suppliers producing company products
Own supplier approval and qualification processes, including audits and quality system assessments
Drive supplier development initiatives to improve process robustness, capability, and inspection readiness
Manage supplier change control, including supplier process changes, transfers, and equivalency evaluations
Plan and execute supplier validation and approval activities aligned with internal procedures and regulatory expectations
Apply and reinforce GMP and ISO-based standards in daily supplier quality operations
Provide end-to-end project management for supplier and part qualification activities (planning, scheduling, tracking, execution, and delivery)
Identify, assess, and mitigate supplier quality risks; escalate issues early with mitigation actions
Partner with cross-functional teams such as R&D, Manufacturing, Quality, and Inspection Systems to support supplier decisions and continuous improvement
Ensure compliance with FDA, ISO, and applicable regulatory standards
Qualification
Required
Experience working with external vendors / manufacturing suppliers
Strong background in Supplier Quality Assurance
Hands-on experience in Supplier Qualification and Onboarding
Experience managing supplier risk and quality issues
Knowledge of Process Validation (IQ, OQ, PQ) and Process Verification
Experience coordinating with cross-functional internal teams and external suppliers
Minimum 5 years of experience in medical device or pharmaceutical industry
Strong understanding of FDA and ISO regulations (FDA CFR Part 820, ISO 13485, ISO 14971)
Strong analytical and problem-solving skills
Excellent verbal and written communication skills
Strong organizational and planning abilities
Ability to work independently and manage multiple priorities
Willingness to work with offshore teams and across time zones
Ability to handle conflicts and drive resolution
Preferred
Six Sigma, Lean, or Lead Auditor certification is a plus
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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