Katalyst CRO ยท 1 day ago
Senior Quality Engineer
Irvine, CA
Contract
Onsite
Mid, Senior Level
3+ years expKatalyst CRO is seeking a Senior Quality Engineer to perform Quality Engineering activities supporting product development and ongoing cleanroom build efforts. The role involves ensuring compliance with quality systems and regulatory standards while working cross-functionally to support design verification and commercialization activities.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Perform Quality Engineering activities related to product development and ongoing cleanroom build support
Ensure NPD processes comply with quality system and applicable regulatory standards
Update risk management and design control files and maintain relevant quality documentation
Develop and execute test method validations and qualification plans
Support design verification and facilitate process validation and commercialization activities related to multi-site transfer
Work collaboratively with cross-functional teams including R&D, manufacturing, regulatory, clinical, and marketing
Perform other duties as assigned by Leadership
Qualification
Required
Bachelor's degree in Engineering or Scientific field with 4+ years of experience OR Master's degree or equivalent in Engineering or Scientific field with 3+ years of experience
Proficient understanding of medical device operations and/or manufacturing processes (medical device experience strongly preferred)
Relevant experience in product development, quality assurance, and/or related fields
Knowledge and understanding of Engineering and Quality principles, theories, and concepts
Understanding of ISO 13485
Experience developing, updating, and maintaining technical content of risk management files
Basic understanding of statistical techniques; experience using statistical software (e.g., Minitab) is a plus
Experience in test method development including validation and/or fixture development
Solid problem-solving, organizational, analytical, and critical thinking skills
Strong documentation and communication skills with attention to detail
Ability to build productive working relationships across all organizational levels
Ability to manage competing priorities in a fast-paced environment
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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