Katalyst CRO ยท 2 months ago
Sr. Quality Assurance Engineer
Merrimack, NH
Contract
Onsite
Senior LevelKatalyst CRO is a company focused on quality assurance in manufacturing. They are seeking a Senior Quality Assurance Engineer to develop and implement QA standards, support manufacturing operations, and lead investigations to ensure product quality and compliance.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Plan, develop, and implement QA standards, inspection, and testing procedures
Support manufacturing operations to ensure product quality and compliance
Lead failure investigations, root cause analysis, and CAPA implementation
Evaluate vendor quality performance and recommend improvements
Review Engineering Change Orders for compliance with quality standards
Support customer and regulatory audits and drive closure of findings
Manage RMA processes and quality metrics for leadership reporting
Support MES configuration to ensure traceability and compliance
Collaborate with cross-functional teams for quality input in verification activities
Prepare and present quality performance metrics for program reviews
Qualification
Required
Plan, develop, and implement QA standards, inspection, and testing procedures
Support manufacturing operations to ensure product quality and compliance
Lead failure investigations, root cause analysis, and CAPA implementation
Evaluate vendor quality performance and recommend improvements
Review Engineering Change Orders for compliance with quality standards
Support customer and regulatory audits and drive closure of findings
Manage RMA processes and quality metrics for leadership reporting
Support MES configuration to ensure traceability and compliance
Collaborate with cross-functional teams for quality input in verification activities
Prepare and present quality performance metrics for program reviews
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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