Katalyst CRO ยท 2 months ago
Sr. Development Quality Engineer
Pleasanton, CA
Contract
Onsite
Senior Level
5+ years expKatalyst CRO is seeking a Sr. Development Quality Engineer to provide design quality expertise to a product development team. The role involves leading risk management activities, supporting design verification and validation, and ensuring compliance with regulatory requirements to achieve patient safety and customer satisfaction.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Lead and/or support on-time completion of Design Control deliverables
Support the establishment of objective, measurable, and verifiable product requirements
Support Design Verification and Validation planning & execution, including any cross-functional investigation & resolution activities
Lead Risk Management activities from product concept through commercialization
Support test method development and lead test method validation activities
Support manufacturing process development & qualification for new product and design changes
Support the establishment of component specification definitions, supplied component sampling plan development, and vendor qualifications
Support biocompatibility and sterilization qualifications
Support audits and quality system improvement activities
Support Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory requirements
Comply with Client, U.S. FDA, EUMDR and other requirements, as applicable
Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and suppliers
Qualification
Required
Bachelor's degree in engineering or Technical Field
Minimum of 5 years of experience in R&D, Process/Manufacturing Engineering, and/or Quality with at least 2 years supporting product development
Experience in medical devices and associated regulations/standards
Experience in test method development and validation
Experience in preparing risk assessments, FMEA and other risk documents
Knowledge of requirements management tools (e.g., DOORS) and use of problem reporting systems (e.g., JIRA)
Working knowledge of statistics and its application to verification and validation
Preferred
Advanced Degree in Engineering/Technical Field
Experience in active implantable medical devices
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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