KH
Senior Quality Engineer
Katalyst Healthcares & Life Sciences
- 🇺🇸 United States
- On-site
- Senior
- 9 hours ago
- CAPA
- PFMEA
- Lean Manufacturing
- Six Sigma
- Kaizen
- SPC
- FMEA
- GD&T
- CAD
- welding
9 hours ago
- Lead manufacturing, plant, product, supplier, and reliability quality activities across high-volume manufacturing and assembly operations.
- Develop, implement, and maintain Quality Management Systems (QMS) in accordance with applicable ISO standards and company requirements.
- Drive continuous quality improvement initiatives across manufacturing processes to reduce defects, scrap, rework, and customer complaints.
- Perform structured Root Cause Analysis using 8D, 5 Why, Fishbone Diagram, and other problem-solving methodologies.
- Lead the development and implementation of Corrective and Preventive Actions (CAPA) and verify their effectiveness.
- Support and manage APQP, PPAP, DFMEA, PFMEA, Control Plans, and Product Development Quality activities.
- Analyze customer complaints, warranty claims, field failures, production non-conformities, and internal quality issues to identify root causes and implement corrective actions.
- Collaborate with Design Engineering, Manufacturing, Operations, Supply Chain, Production, and Supplier teams to resolve quality and reliability issues.
- Lead continuous improvement programs using Lean Manufacturing, Six Sigma, Kaizen, Poka-Yoke, and other quality improvement methodologies.
- Develop and maintain SPC, MSA, FMEA, Control Plans, Process Audits, Risk Assessments, and other quality documentation.
- Monitor manufacturing processes and establish appropriate quality controls to ensure products meet customer and engineering specifications.
- Conduct supplier quality audits, supplier assessments, and supplier development activities.
- Work with suppliers to identify quality issues, establish corrective actions, and improve supplier performance.
- Review and interpret engineering drawings, specifications, GD&T requirements, CAD data, and product documentation.
- Support manufacturing processes including machining, fabrication, assembly, casting, welding, electrical assembly, and process manufacturing.
- Lead quality investigations involving process deviations, non-conforming materials, production defects, and product failures.
- Establish and monitor key quality metrics and prepare quality reports, dashboards, and management presentations.
- Lead cross-functional quality teams and coordinate activities among quality engineers, inspectors, technicians, manufacturing engineers, suppliers, and operations personnel.
- Minimum 12+ years of experience in Manufacturing Quality, Plant Quality, Supplier Quality, Product Quality, or Reliability Engineering.
- Proven experience driving quality improvements in high-volume manufacturing and assembly environments.
- Strong understanding of Quality Management Systems (QMS), ISO standards, and manufacturing quality processes.
- Hands-on experience in Root Cause Analysis using methodologies such as 8D, 5 Why, Fishbone Diagram, or similar structured problem-solving tools.
- Experience implementing and sustaining Corrective and Preventive Actions (CAPA).
- Strong knowledge of APQP, PPAP, DFMEA, PFMEA, Control Plans, and Product Development Quality processes.
- Experience analyzing customer complaints, warranty claims, field failures, and production non-conformities.
- Ability to work effectively with Design, Manufacturing, Supply Chain, Operations, and Supplier teams to resolve quality issues.
- Experience leading continuous improvement initiatives using Lean Manufacturing, Six Sigma, Kaizen, Poka-Yoke, or equivalent methodologies.
- Strong understanding of manufacturing processes such as machining, fabrication, assembly, casting, welding, electrical assembly, or process manufacturing.
- Experience with supplier quality management, supplier audits, and supplier development activities.
Senior Quality Engineer · Katalyst Healthcares & Life Sciences