Katalyst CRO ยท 1 month ago
Sr. Design Quality Engineering
Irvine, CA
Full-time
Onsite
Senior LevelKatalyst CRO is a company focused on ensuring quality engineering activities for released products. The role involves ensuring compliance with regulatory standards, supporting risk management, and collaborating with cross-functional teams on product validation and quality assurance activities.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Ensure quality engineering activities for released products comply with regulatory and internal standards
Collaborate with cross-functional teams to develop product risk management documentation, including Risk Management Plans, Risk Assessments, DFMEA, and Risk Management Reports
Support the development and execution of Verification and Validation (V&V) plans, protocols, and reports, Test Method Validation, as well as process validation activities (PFMEA, IQ, OQ, PQ) using statistical tools (e.g., Minitab) for data analysis and decision-making
Oversee product testing and analysis to ensure compliance with applicable standards and requirements
Apply Design Control principles to support sustaining engineering efforts, including design updates and product enhancements
Resolve quality issues, manage design changes, and assess risks in partnership with engineering, manufacturing, and quality teams
Apply risk management techniques to proactively identify and mitigate product risks
Use structured problem-solving methodologies to address product and process challenges
Communicate findings effectively through presentations, technical reports, and cross-functional collaboration
Qualification
Required
Experience supporting Verification & Validation, process validation, risk management, and sustaining engineering activities
Proficiency in using statistical tools such as Minitab for data analysis
Knowledge and experience applying Design Controls and risk management techniques in engineering environments
Ability to work collaboratively across engineering, manufacturing, and quality teams
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