EMANUEL ABUNDEZ
Lockhart,United States
Summary
Effective quality professional bringing proven success in driving continuous improvement initiatives in Quality Engineer roles. Focused and diligent with commitment to fostering corporate mission. Consistently acknowledged for implementing actionable initiative to reduce error rates and optimize company processes.
Overview
10
10
years of professional experience
Work History
Senior Design Quality Engineer
Smith+Nephew
2022.09 - Current
- Provide quality leadership to product support project teams as quality engineering representative
- Work with cross functional teams to develop methods and procedures to ensure that appropriate tests are conducted to ensure that products meet required specifications/standards and that safety and reliability of products are established
- Generate/approve/manage design verifications, design validations, sterilization validations, process validations, supplier qualifications, test methods, capability studies, and risk management documentation
- Support establishing contract manufacturer and internal manufacturing operations
- Provide expertise in product requirements, risk management, test methods, and statistical analysis
- Ensure compliance to product specific standards, including but not limited to: cGMP, QSR, US FDA, ISO, IEC, UL, EN, EU MDR and MDD requirements
- Ensure that a responsibilities within the scope of this job comply with the scope of the Quality System
- Work with outside labs and suppliers to communicate Smith & Nephew product / process requirements as well as assess capabilities of the outside lab / supplier
- Support Management Review, internal/external audits/inspections, continuous improvement activities (CAPA), and Post Market Surveillance activities.
Design Quality Engineer II
Smith+Nephew
2018.04 - 2022.09
- Provide quality leadership to sustaining project teams as the quality engineering representative and procedures to ensure that the appropriate tests are conducted to ensure that products meet the required specifications/ standards and that the safety and reliability of products are established
- Generate/approve/manage design verifications, design validations, sterilization validations, process validations, supplier qualifications, test methods, capability studies, and risk management documentation
- Support manufacturing operations and provide expertise in product requirements, risk management, test methods, and statistical analysis including measurement system analysis
- Ensure compliance to product specific standards, cGMP, QSR, US FDA, ISO, IEC, UL, EN, and MDD requirements
- Ensure that all the responsibilities within the scope of this job comply with the scope of the Quality System
- Work with outside labs and suppliers to communicate Smith & Nephew product / process requirements as well as assess capabilities of the outside lab / supplier
- Support continuous improvement activities (CCRs and/or PARs)
- Support Post Market Surveillance activities, Management Review, and audits/inspections
- Assist in reviewing and the closure of the complaint process
- Support Measurement System Analysis studies.
Quality Assurance Engineer I
Smith+Nephew
2016.04 - 2018.04
- Developed instructions for Critical to Quality determination methods with a cross-functional team
- Provided quality leadership to sustaining project teams as the quality engineering representative and ensured that the appropriate tests were conducted to ensure that products meet the required specifications/standards and that the safety and reliability of products were established
- Generated/approved/managed design verification, design validations, sterilization validations, process validations, supplier qualifications, test methods, capability studies, and risk management documentation
- Supported manufacturing operations by providing expertise in product requirements, risk management, test methods, and statistical analysis including measurement system analysis
- Ensured compliance to product specific standards, cGMP, QSR, US FDA, ISO, IEC, UL, EN, and MDD requirements
- Ensured that all the responsibilities within the scope of this job comply with the scope of the Quality System
- Worked with outside labs and suppliers to communicate Smith & Nephew product / process requirements as well as assess capabilities of the outside lab / supplier
- Supported Post Market Surveillance activities, Management Review, and audits/inspections.
Professional Services Engineer
Weatherford
2014.07 - 2016.04
- Implemented and managed complex software implementation projects for enterprise clients
- Collaborated with cross-functional teams to ensure seamless integration of products into client environments
- Derived method to calculate future inventory based on current flow data
- Developed reports to assist plant managers to assess overall health of plant
- Utilized HMI to monitor critical data and PLCs to monitor thermal activity in wells
- Provided technical expertise and support to customers throughout software deployment process
- Devised custom solutions to meet clients' specific needs and requirements, ensuring satisfaction and retention by 15%.
Education
Bachelor of Science - Mechanical Engineering
The University of Texas-Pan American
Edinburg, TX05.2014
Skills
- Risk Management
- Design Control
- Post-Market Surveillance
- Root Cause Analysis
- Quality Documentation
- Decision-Making
- Test method validation
- Issue Resolution
- Non-conforming material reports
- Corrective Action Planning
- Protocol Review
- Failure Modes and Effects Analysis
- Project Scheduling
- Critical Thinking
- Process Optimization
- Corrective and Preventive Actions
References
- Maria Jesus Perez, Former Manager, (351) 220-5350, Ameymary@gmail.com, 07/2019, 04/2020
- Lou Balogh, Former Manager, (408) 242-2168, louiebalogh@gmail.com, 04/2016, 06/2018
Timeline
Senior Design Quality Engineer
Smith+Nephew
2022.09 - Current
Design Quality Engineer II
Smith+Nephew
2018.04 - 2022.09
Quality Assurance Engineer I
Smith+Nephew
2016.04 - 2018.04
Professional Services Engineer
Weatherford
2014.07 - 2016.04
Bachelor of Science - Mechanical Engineering
The University of Texas-Pan American
Similar Profiles
Cherielyn O'ConnorCherielyn O'Connor
Loanset Technician at Smith+NephewLoanset Technician at Smith+Nephew
Katie FultonKatie Fulton
Order Management Specialist at Smith+NephewOrder Management Specialist at Smith+Nephew
Svetlana LarsonSvetlana Larson
Advanced Manufacturing Engineering Manager at Smith+NephewAdvanced Manufacturing Engineering Manager at Smith+Nephew