Katalyst CRO ยท 3 days ago
Quality Engineer
Cortland, NY
Contract
Onsite
Mid Level
3+ years expKatalyst CRO is a company focused on quality engineering initiatives across various sectors. The role involves ensuring products meet regulatory, customer, and internal quality requirements through effective process controls and supplier quality management.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Develop, implement, and maintain quality engineering methodologies and process control systems
Support supplier quality performance through Part Quality Plan (PQP) implementation, review, and approval
Conduct supplier qualification activities, including audits and compliance assessments
Ensure supplier adherence to Quality Management System (QMS) and regulatory requirements
Lead or support Corrective and Preventive Action (CAPA) activities using root cause analysis methodologies
Apply systematic problem-solving techniques to identify, communicate, and resolve quality issues
Participate in cross-functional quality initiatives supporting product development, operations, and continuous improvement
Maintain compliance with all quality system requirements and documentation standards
Qualification
Required
Bachelor's degree in Engineering or a technical discipline (or non-technical degree with 5+ years of relevant manufacturing, engineering, or quality experience)
Minimum 3 years of experience in quality engineering, manufacturing, engineering design, or regulatory assurance
Strong analytical, problem-solving, and root cause analysis skills
Ability to influence cross-functional teams and suppliers to drive quality improvements
Preferred
ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA)
Experience with QMS tools and continuous improvement methodologies
Supplier quality experience within the medical device or regulated manufacturing industry
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