What are the responsibilities and job description for the Senior Supplier Quality Engineer position at Katalyst CRO?
Job Summary
The Senior Supplier Quality Engineer is responsible for managing and improving supplier quality performance across the supply chain. This role works closely with suppliers, Engineering, Manufacturing, Quality, Procurement, and Operations teams to ensure purchased materials, components, and services meet established quality and regulatory requirements.
Key Responsibilities
The Senior Supplier Quality Engineer is responsible for managing and improving supplier quality performance across the supply chain. This role works closely with suppliers, Engineering, Manufacturing, Quality, Procurement, and Operations teams to ensure purchased materials, components, and services meet established quality and regulatory requirements.
Key Responsibilities
- Lead supplier qualification, evaluation, and approval activities.
- Develop and maintain supplier quality requirements, specifications, and quality agreements.
- Conduct and support supplier audits, assessments, and process reviews.
- Lead supplier SCAR/CAPA activities and drive timely corrective and preventive actions.
- Investigate supplier-related nonconformances, defects, and quality issues using root-cause analysis.
- Monitor supplier performance using quality metrics, scorecards, PPM, defect rates, and delivery performance.
- Partner with suppliers to implement process improvements and defect-reduction initiatives.
- Support PPAP, APQP, FAI, inspection plans, and process validation activities as applicable.
- Review supplier engineering changes and assess their potential quality and regulatory impact.
- Support incoming inspection requirements and disposition of supplier-related material issues.
- Collaborate with Engineering, Manufacturing, Procurement, Quality, and Regulatory teams on supplier quality issues.
- Provide technical guidance to suppliers on quality system and process requirements.
- Support internal, customer, and regulatory audits related to supplier quality.
- Identify supplier risks and develop appropriate mitigation and continuous improvement strategies.
- Bachelor's degree in Mechanical Engineering, Industrial Engineering, Manufacturing Engineering, Quality Engineering, or a related technical field.
- 6 years of experience in Supplier Quality, Quality Engineering, Manufacturing Quality, or a related discipline.
- Strong experience with supplier audits, SCAR, CAPA, RCA, and nonconformance management.
- Experience with supplier qualification and performance management.
- Strong understanding of quality systems and manufacturing processes.
- Experience with FMEA, SPC, MSA, control plans, and process capability.
- Knowledge of PPAP, APQP, First Article Inspection (FAI), and supplier development.
- Experience working with cross-functional engineering, manufacturing, procurement, and quality teams.
- Strong analytical, problem-solving, communication, and project-management skills.
- Experience in medical device, pharmaceutical, aerospace, automotive, or other regulated manufacturing.
- Knowledge of ISO 13485, ISO 9001, FDA 21 CFR Part 820/QMSR, or applicable industry standards.
- ASQ Certified Quality Engineer (CQE) or Certified Supplier Quality Professional certification.
- Lean Six Sigma Green Belt or Black Belt certification.
- Experience with SAP, Oracle, TrackWise, Veeva, ETQ, or other QMS/ERP systems.
- Experience with machining, injection molding, plastics, electronics, metal fabrication, or other complex manufacturing processes.