What are the responsibilities and job description for the Quality Engineer position at Katalyst CRO?
Job Summary
- 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.
- 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.