What are the responsibilities and job description for the Quality Engineer position at Katalyst Healthcares & Life Sciences?
Summary:
The Quality Engineer ensures the consistent quality of products and processes through audits, inspections, testing, analysis, and continuous improvement activities. This role supports manufacturing and cross functional departments by conducting defect and trend analysis, troubleshooting, monitoring calibration, and reporting on results of measurement standards. The Quality Engineer also partners with suppliers and internal value streams to validate processes, support data interpretation, and reinforce adherence to Quality Management System (QMS) standards.
Roles & Responsibilities:
The Quality Engineer ensures the consistent quality of products and processes through audits, inspections, testing, analysis, and continuous improvement activities. This role supports manufacturing and cross functional departments by conducting defect and trend analysis, troubleshooting, monitoring calibration, and reporting on results of measurement standards. The Quality Engineer also partners with suppliers and internal value streams to validate processes, support data interpretation, and reinforce adherence to Quality Management System (QMS) standards.
Roles & Responsibilities:
- Lead and coordinate customer quality complaint resolution with the manufacturing value stream for root cause investigation and CAPA, 8D reporting.
- Review CAPA from the manufacturing value stream to determine the robustness and effectiveness verifications.
- Work with the individual manufacturing value stream to implement QMS improvements and maintain documentation.
- Attend daily management (DM) activities to provide quality updates and input.
- Lead daily internal Material Review Board (MRB) activities and coordinate scrap review in the scrap marketplace.
- Drive material scrap reduction initiatives in collaboration with Production and Engineering teams.
Qualifications:
- Bachelor's degree or equivalent experience.
- Knowledge of ISO 9001, (current rev) to aid in maintaining QMS
- 5 years' experience in a Quality Engineering role.
- Working knowledge in statistical tools (such as SPC, MSA, Pareto, ANOVA etc.) and quality tools (such as FMEA, Cause and Effect Diagram, 8D etc.).
- Proficient in software such as Microsoft Office, SAP, Pilgrim/Smart Solve
- Exceptional communication skills, Ability to interact with all areas, Team player.
- Continuous Improvement Activities, Lean Manufacturing Principles, 5S, Kaizen
- Drive material scrap reduction initiatives in collaboration with Production and Engineering teams.