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I am an experienced Quality/Manufacturing/Process Engineer of 24 years with a background in design, regulatory, process, validation, complaint handling, project management, root cause analysis and inspection methods in both automotive and medical device industries. I am knowledgeable in FDA and ISO regulations. Strong verbal and written communication skills. My continuous challenges and process six sigma improvement activities for 24 years have been in Quality and Regulatory Systems in both low and high volume, automotive ,electro-mechanical med-device and prosthetic industry. This has involved managing people and implementing compliance/customer driven Quality in an environment of GMP, ISO/EN, MHLW and QSR
Generac Clean Energy
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Generac Clean EnergyReno, Nevada, United States
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Sr. Process EngineerTesla Feb 2022 - Jun 2024Austin, Texas, UsExperience in maintaining stringent quality standards through adherence to control plans and implementation of process improvements. Enhanced Process Change Authorization procedures, ensuring efficiency and compliance. Acted as a pivotal liaison between departments, supporting Validation Engineering while coordinating process enhancements. Experience in reviewing and developing validation protocols, as well as implementing validation processes across manufacturing lines. Improved First Pass Yield (FPY) by optimizing incoming quality and aligning processes with performance objectives. Adept at developing methods, specifying parameters, and recommending corrective actions to address procedural or product deficiencies. Experience in gathering and analyzing operational and test data, contributing to process evaluation and refinement. Ensured compliance with specifications and industry standards, utilizing technical drawings and inspection measures to uphold quality benchmarks. Ensured product reliability through rigorous testing and evaluation processes. Experience with investigating and resolving corporate complaints related to materials production. Experience with facilitating the launch of new products and processes while ensuring adherence to corporate quality standards and regulations. Experience in conducting validations and completing reports for new and existing products, processes, and equipment, supported by statistical analysis. -
Product Quality EngineerVarian Jan 2020 - Jan 2022Palo Alto, Ca, Uso Ensured the design and development processes are followed, specific controls are in place and documented to ensure adequate quality at all product realization stages.o Ensured compliance to current regulatory procedures and changes throughout the complete product life cycle.o Supported internal and external audits, collaborated with cross-functional teams, and maintained compliance with relevant regulations including 21CFR part 820 ,UL, , Directive 93/42/EEC, Regulation (EU) 2017/745, ISO 13485, and ISO 14971.o Experienced in interfacing with FDA and ISO qualified bodies, serving as a lead auditor, and managing ISO and FDA recertification efforts. o Ensured compliance to requirements according to 21CFR part 820, Directive 93/42/EEC, Regulation (EU) 2017/745, ISO 13485, ISO 14971, and other applicable regulations and standards.o Experience in conducting validations and completing reports for new and existing products, processes, and equipment, supported by statistical analysis. o Review of the design and development documentation for adequacy and ensures that they are consistent with the company wide, global processes.o Played a key role in design and development phases, overseeing risk management and implementing controls for final production stages.o Involved in design and development phase from beginning to support risk management and to implement the required controls at the final production stage.o Supported engineering teams with the root cause analysis and corrective actions implementation.o Experienced in New Product Introduction/Design Transfer activities to characterize manufacturing processes for parts/components in development to ensure smooth transition from R&D to manufacturing, including participation and leadership of the development of equipment and process validation requirements (FMEA, IQ, OQ, PQ) using appropriate statistical tools and techniques. -
Quality Assurance / Regulatory Affairs ManagerSunetics International Marketing Group, Llc Aug 2015 - Sep 2016o Utilized quality tools such as: design controls, quality system auditing, inspection methods, design verification and validation and process validation o Managed and executed all aspects of quality management program ("Quality System") to include: strategic planning, resource allocation, and system design control o Directed and implemented the development of policies and procedures through which products are submitted for approval inside and outside the United Stateso Served as the Quality Management Representative to the FDA and notified regulatory auditing entitieso Experienced in adherence to standards under FDA, UL, MDD, and ISO13485 requirements, and designs/modified Quality System accordingly to complyo Provided technical expertise and opinions related to interpretation of FDA and ISO requirements and UDI requirementso Experienced as a Lead Auditor -
Sr. Quality Assurance EngineerInovalabs Mar 2015 - May 2015o Contract Quality Engineero Primary responsibility was risk management mitigation activitieso Corrective Actions and Preventative Actions implementation and updates to existing files
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Quality Regulatory Engineer IiiInnovative Neurotronics Apr 2007 - Mar 2015Us• UDI program manager• Developed and implemented product specific process trending and metrics.• Developed and implemented product specific CAPA trending and metrics• Developed and implemented Design Control process to meet compliance requirements.• Maintained compliance for ISO 13485:2003 • Maintained process Approach quality system documentation• Implemented ISO 13485 3rd edition and RoHS 2• Established and managed a Quality Assurance department. • Expanded markets into Korea, Brazil and Japan • Oversight of all QAE responsibilities• Maintained Design Control and implemented Change Control Management• Oversight of two ECM changes due to quality or acquisition• Implemented and Validated ETQ Reliance software Quality System• Began employment by resolving a Recall and Warning Letter situation• FDA liaison during audits (Management Representative)• Experienced as a Lead auditor both internal and external audits -
Manufacturing EngineerEncore Medical Aug 2004 - Nov 2006o Engineering duties focusing on Process and Product support concerning all the various orthopaedic product families (hip, knee, spine, shoulder and trauma)o Provide process support and process optimization and managed all validation activities for the manufacturing of orthopedic products
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Quality Process EngineerDepuy Orthopaedics Aug 2001 - Aug 2004o Oversaw the manufacturing processes and process improvement for PFC Sigma knees o Authored and executed the process validations for the PFC Sigma Rotating platform high flexion knee o Project leader of the Global Harmonization of Cosmetic Standards for all implants plastic and metalso Project leader overseeing the successful product transfers of both (current and new) domestic and international divisionso Supported the Trauma product lines in handling complaints and discrepancies
Sidney Bennett Skills
Sidney Bennett Education Details
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California Polytechnic State University-San Luis ObispoBiomedical Engineering -
California Polytechnic State University-San Luis ObispoMechanical Engineer
Frequently Asked Questions about Sidney Bennett
What company does Sidney Bennett work for?
Sidney Bennett works for Generac Clean Energy
What is Sidney Bennett's role at the current company?
Sidney Bennett's current role is SR. Quality Engineer.
What is Sidney Bennett's email address?
Sidney Bennett's email address is sb****@****.rr.com
What is Sidney Bennett's direct phone number?
Sidney Bennett's direct phone number is +151247*****
What schools did Sidney Bennett attend?
Sidney Bennett attended California Polytechnic State University-San Luis Obispo, California Polytechnic State University-San Luis Obispo.
What are some of Sidney Bennett's interests?
Sidney Bennett has interest in Social Services.
What skills is Sidney Bennett known for?
Sidney Bennett has skills like Medical Devices, Iso 13485, Product Development, Capa, Auditing, Quality Assurance, Process Control, Process Improvement, Risk Management, Complaint Management, Fda Gmp, Validation.
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