Katalyst CRO
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Quality Engineer
role at
Katalyst CRO .
Responsibilities
Support quality engineering initiatives across supplier quality, manufacturing, and quality systems. Ensure products meet regulatory, customer, and internal quality requirements through effective process controls, CAPA execution, and supplier quality management.
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.
Qualifications
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).
Preferred: Experience with QMS tools and continuous improvement methodologies.
Preferred: Supplier quality experience within the medical device or regulated manufacturing industry.
Seniority Level Associate
Employment Type Contract
Job Function Quality Assurance
Industry Pharmaceutical Manufacturing
Location Lansing, NY - Salary $70,000-$77,000 (1 day ago)
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Quality Engineer
role at
Katalyst CRO .
Responsibilities
Support quality engineering initiatives across supplier quality, manufacturing, and quality systems. Ensure products meet regulatory, customer, and internal quality requirements through effective process controls, CAPA execution, and supplier quality management.
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.
Qualifications
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).
Preferred: Experience with QMS tools and continuous improvement methodologies.
Preferred: Supplier quality experience within the medical device or regulated manufacturing industry.
Seniority Level Associate
Employment Type Contract
Job Function Quality Assurance
Industry Pharmaceutical Manufacturing
Location Lansing, NY - Salary $70,000-$77,000 (1 day ago)
#J-18808-Ljbffr