Quality Consultant with more than 8 years of experience in a highly regulated environment centered on compliance and delivery of high-quality risk assessment, design, implementation, validation, and maintenance solutions. Extensive experience in Verification and Validation, Risk Management and Quality Engineering in the medical device industry. Hands on experience in Design controls and DHFs, DFMEA, PFMEA and FTA Analysis. Performed PPAP, APQP, First Article Inspections (FAI) and Incoming Inspections.
My Skills Set
- Responsible for Quality Assurance of Design activities for manufacturing and Engineering on all programs.
- Provided Engineering support to product and process design, including risk management review, classification of quality characteristics, design inputs and review, technical drawings and specifications, and design verification and validation
- Wrote, Reviewed and approved all design control risk management documents such as plans, hazard analyses, and design and process FMEA's, and reports.
- Reviewed and analyze in-process and finished product testing and inspection results to ensure the Validations met company top level procedures and FDA regulations.
- Supported the manufacturing facilities by evaluating non-conformances and participating in NCBs to address issues.
- Reviewed product and process control methods documents to ensure that criteria for identifying critical control points are met.
- Worked on critical engineering projects that include Risk Management Planning, Remediation of product lines, Hazard Analysis, DFMEA, PFMEA, Design Control, and Hazard Analysis.
- Reviewed documents related to DHF, DHR, DMR, Design and Development, Validation and Verification for Regulatory compliance
- Coordinated with Research & Development to suggest and keep standards in Quality support including supplier coordination with FMEA, Control Plan development, and first article approvals
- Product, Process, and Design through Quality Functional Development and risk analysis.
- Involved in Design Analysis production failures and process deviations for trends and root causes
- Responsibility as the Quality representative throughout new product Design & Development
- Responsible for quality engineering support for existing products
- Risk Management: FMEA and fault tree analysis
- Conducting daily audits with Quality, Production and Manufacturing officials to discuss about the quality issues and implementing corrective actions.
- Ensure use of PFMEA, Control Plan, Process Mapping and monitoring the actions based on the plan
- Assisted in conducting 5S training
- Perform root cause analysis using 5 Why, 8D and advanced problem-solving methods
- Understands all customer requirements on quality and communicates these requirements to the work force as required
- Collaborated with production, process and engineering to implement quality controls
- Conducted failure analysis; found root-cause, taken corrective action.
University of Illinois
Name JOSE VALDEZ
Location 1 square street, New York, USA
Marital Status Married
Education Manufacturing Engg. (University of Illinois )
Experience Spectranetics (Quality Engineer)