Katalyst Healthcares and Life Sciences
Responsibilities:
- Evaluates potential new suppliers through technical capability assessments, ensuring they meet the company's rigorous standards and can deliver high-quality components and assists in the supplier selection.
- Executes DFMAT (Design for Manufacturing and Assembly Technique), SAF (Supplier Approval Form), MSA (Measurement System Analysis), PFMEA (Process Failure Mode and Effects Analysis), Control Plan, SPC (Statistical Process Control), PV&V (Process Validation and Verification), FAI (First Article Inspection), LRA (Logistics Risk Assessment), and SICR (Supplier Initiated Change Request).
- Executes, monitors, and controls APQP (Advanced Product Quality Planning) processes during NPI projects to maintain consistent quality and adherence to project timelines.
- Ensures Critical to Quality (CtQ) characteristics are clearly communicated to suppliers and rigorously maintained throughout the production process, securing consistent product quality.
- Executes Part Submission Warrant plans, deliverables, line releases, and completion, ensuring that all parts meet specified quality standards before they are approved for use.
- Supports supplier improvement and development on APQP, providing guidance and resources to help suppliers enhance their quality processes and achieve compliance.
- Manages supplier non-conformities by working with operations team.
- Communicates non-conformities with suppliers, raises notification and/or SCARs.
- Drives root cause investigations at suppliers to prevent recurrence of the issue.
- Bachelor's degree in engineering science, Supply Chain Management, Electrical Engineering, Electronic Engineering or equivalent.
- 3 years of experience in Quality Engineering, Supplier Quality, Process Engineering, Continuous Improvement Techniques.
- Supplier Quality Management.
- Quality Management Procedures and Methodologies.
- Supplier Evaluation Methodologies.
- Data Analysis & Interpretation.
- DfX Methodology.
- Supply Chain Management (SCM).
- Quality Specifications.
- CAPA Methodologies.
- Statistical Process Control (SPC).
- Measurement Systems Analysis (MSA).
- Process Validation and Verification (PV&V).
- First Article Inspections.
- Documentation & Reporting.
- Continuous Improvement.
- Problem Solving.