marcos carrandi

Functional Process Engineering Roles include production and process controls: Process Validation (IQ, OQ, PQ and PPQ), Work Instructions, SOPs, Process Flow Diagram, PM and HHA/PFMEAs for Operations. Ensure quality issues are managed according to procedure and ensure adequate corrective/preventive actions are effective to eliminate/mitigate the issues.

Consultant to Fresenius Medical Care, Irving, Texas, for the Concentrate Product Lines. Provide and lead OQ/PQ Validation projects, Corrective Action and Preventive Action (CAPA) investigations as well as Non-Conformance (NC) investigations and process activities. Demonstrate leadership in organizing and driving solution based teams. Ensure compliance to process requirements and the consistency/quality of Corporate CAPAs and NCs. Lead root cause analysis investigations and drive continuous improvement efforts on an ongoing basis.

Consultant to Stryker Sustainability Solution, Lakeland, Florida, for the Ultrasonic ACE Scalpels reprocessed Harmonic cauterization device line. Functional Engineering Roles include: Design Control compliance assessments, quality systems remediation development & implementation, design improvement development, risk management alignment, verification and validation design and implementation, workflow development. ISO, FDA CFR & QSR Compliance Assurance and Auditing.

Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provides focused quality engineering support within new product development, operational, or system/services support. Functional Engineering Roles include: Design Assurance, Operations Quality, Software Engineering, Supplier Assurance, Product Analysis, Metrology, Microbiologist, Chemist

* Engineering * Quality Assurance * Manufacturing Operations * Six Sigma * New Product Development * Supply Quality Assurance * Validation * Medical Device Industry * Consumer Product Industry * Consulting

Cook Medical is a family owned company with more than 11,000 employees. For the past 53 years, we've been working with physicians to find simpler and safer ways to treat their patients. What started with three simple products has grown into a global company serving 135 countries across the Americas, Europe, Asia, Africa and Australia. Today, we build medical devices for more than 40 medical specialties.