Katalyst CRO · 3 months ago
Sr. Development Quality Engineer
Pleasanton, CA
Contract
Onsite
Senior Level
5+ years expKatalyst CRO is seeking a Sr. Development Quality Engineer to serve as a technical quality leader within a product development team. The role focuses on ensuring patient safety, product reliability, and full regulatory compliance across all phases of development.
Enterprise SoftwareBig DataPharmaceuticalHuman ResourcesAnalyticsBiopharmaData ManagementQuality Assurance
Responsibilities
Lead Design Control and Risk Management activities from concept to commercialization
Support Verification & Validation (V&V) and Test Method Validation
Partner with cross-functional teams in R&D, Manufacturing, and Quality
Ensure compliance with FDA, EUMDR, and QMS standards
Qualification
Required
Bachelor's in engineering or related field
5+ years in R&D, Manufacturing, or Quality Engineering
Medical Devices experience required
Strong expertise in Test Method Validation
Strong expertise in Risk Documentation
Strong expertise in FMEA
Ensure compliance with FDA, EUMDR, and QMS standards
Preferred
Master's degree
Familiarity with DOORS
Familiarity with JIRA
Familiarity with statistical tools
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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