Eric Jarrett Email & Phone Number

Farmers Branch, Texas, Us

I was added to the Airway Management team as Director of QUality and Regulatory Affairs. I initially ensured that Airway Management made the transition from ISO 13485 2003 and EN ISO 13485 2012 to ISO 13485: 2016. Modified and added necessary documentation to transition the system. The facility was 13485:2016 certified in seven (7) months after completing preliminary and certification audits. In addition, completed training ISO 13485:2016 lead auditor training along with MDR (EU) training to initiate the transition from MDD to MDR (EU). I support the quality and regulatory organization for design, manufacturing, and post market activities. This also includes contract design and development of class I, II medical devices for sleep apnea and related applications.Additional Responsibilities:(Site-level Management of Critical Quality Systems and Medical Device Development Design Controls)- Provide quality and compliance over-site for product development teams- Development and deployment of plant level procedures- Provide training to employees on QS Reg. and ISO quality system requirements- Perform Internal and external quality system audits- Maintain and audit project design history files- Provide six sigma, lean, and design control training for development services organization- Maintain Equipment/Facilities QA records- Maintain CAPA, Internal/External Audits, Nonconforming Material, and Complaint Systems-Guidance and mentorship for six sigma greenbelts and black-belt projects- Perform performance reviews and hire personnel as required-Coordinate lean Kaizan events for quality system and process improvement-Provided transfer due diligence for design transfers to manufacturing.-Site Quality Management Representative-Lead for FDA, SGS, MDSS, and Customer audits

Charlotte, North Carolina, Us

Honeywell Incorporated (Richardson, Texas)(Sensing and Control Design and developer of sensors for automotive functional safety)From 3/2017 to 4/2018Principal Compliance Engineering SpecialistI was initially hired by Honeywell Incorporated as principal compliance engineering specialist for a department of one (1). I was assigned the responsibility to establish the ISO 26262 Automotive Functional Safety Program. In a short period of time, I have created the entire ISO 26262 Automotive Functional Safety Management System (six months) and initiated the ISO 26262 certification process with a selected notified body. Currently, I am walking design and manufacturing teams through the new process for three (3) product lines. Successful launch and ISO 26262 certification is expected for spring 2018.Additional Responsibilities:(Multi-Site-level Management of ISO 26262 Functional Safety Systems- Design and Manufacturing) - Provide functional safety compliance for multi-site teams (product development and manufacturing) - Development and deployment of ISO 26262 global and plant level procedures - Create and Provide training to employees on ISO 26262 Functional Safety Compliance - Perform Internal and external quality system audits - Maintain and audit project/product safety case history files - Provide six sigma, lean, and design control training for ISO 26262 and Wafer Fab development teams -Coordinate lean Kaizan events for quality system and process improvement-Provide ISO 26262 Automobile Functional Safety transfer due diligence for design transfers to multiple facilities in China and Richardson-Sustaining Management of ISO 26262 Functional Safety Programs-Site Quality Management Representative -Lead for TUV ISO 26262 Automotive Functional Safety audits

Senior Quality System and Regulatory Manager I was initially hired by Nypro Healthcare as senior site quality and regulatory manager for a department of one (1). Nypro Healthcare was eventually acquired by Jabil in 2013. I created the entire Quality Management System (QMS) systems in three (months) and initiated the ISO 13485 certification process. The facility was 13485 certified in seven (7) months after completing preliminary and certification audits. In addition, provided over-site for the design and construction of a class 7 clean room. The clean room completed construction in early 2014 and we launched our initial product in December of 2014. I supported the growth of the department and managed seven (2) quality engineers (senior level). The quality organization supported the contract design and development of class I, II, and III medical devices for some of the top medical device companies.Additional Responsibilities:(Site-level Management of Critical Quality Systems and Medical Device Development Design Controls) - Provide quality and compliance over-site for product development teams - Development and deployment of plant level procedures - Provide training to employees on QS Reg. and ISO quality system requirements - Perform Internal and external quality system audits - Maintain and audit project design history files - Provide six sigma, lean, and design control training for development services organization - Maintain Equipment/Facilities QA records - Maintain CAPA, Internal/External Audits, Nonconforming Material, and Complaint Systems -Guidance and mentorship for six sigma greenbelts and black-belt candidates- Perform performance reviews and hire personnel as required -Coordinate lean Kaizan events for quality system and process improvement-Provided transfer due diligence for design transfers to multiple facilities in Mexcico-Site Quality Management Representative -Lead for FDA, TUV, BSI, and Customer audits

Quality System and Compliance ManagerHeaded a newly created department that consisted of seven (7) professionals (Quality Systems Engineer, Documentation Control Supervisor, and four (4) documentation control analyst. In this position, I was responsible for quality management system compliance for Orthofix’s headquarters. The quality management system supported the development and manufacturing of class II and III medical devices (implantable devices).Additional Responsibilities:(Site-level Management of Critical Quality Systems and Regulatory Compliance) - Provide quality andi compliance over-site for product development, manufacturing, & QMS supported activities. - Development and deployment of plant level procedures and electronic systems- Provide training to employees on QS Regulations and ISO quality system requirements - Perform Internal and external quality system audits - Maintain and support software validation for QMS related software solutions- Provide six sigma, lean, design control, and root cause analysis training for development services organization - Maintain Equipment/Facilities QA records - Maintain CAPA, Internal/External Audits, Nonconforming Material, and Complaint Systems -Guide and mentor six sigma greenbelts and black-belt candidates- Assure alignment and integration of all organizational sites and division Quality Management Systems - Perform performance reviews and hire personnel as required -Coordinate Quarterly Management Review Meeting and Monthly KPI metrics -Coordinate lean Kaizan events for quality system improvement

Austin, Texas, Us

Senior Quality Assurance Manager/ Quality EngineeringInitially hired by Avail Medical Products as site quality manager for a department of one (1). Avail Medical Products was eventually acquired by Flextronics in 2008. I supported the growth of the department and managed seven (7) quality engineers (senior to entry level), two (2) engineering technicians, and a documentation coordinator. The quality organization supported the contract design and development of class I, II, and III medical devices for some of the top medical device companies.Additional Responsibilities:(Site-level Management of Critical Quality Systems and Medical Device Development Design Controls) - Provide quality and compliance over-site for product development teams - Development and deployment of plant level procedures - Provide training to employees on QS Reg. and ISO quality system requirements - Perform Internal and external quality system audits - Maintain and audit project design history files - Provide six sigma, lean, and design control training for development services organization - Maintain Equipment/Facilities QA records - Maintain CAPA, Internal/External Audits, Nonconforming Material, and Complaint Systems -Guidance and mentorship for six sigma greenbelts and black-belt candidates- Certified group (12 candidates) of greenbelts in an internal certification process- Perform performance reviews and hire personnel as required -Coordinate lean Kaizan events for quality system and process improvement-Site Quality Management Representative -Lead for FDA and BSI audits

Bad Homburg, Frankfurt, De

Quality Systems Section ManagerProvided key support for quality system process improvement while managing a group five (5) professionals (Quality Engineer, Six Sigma SPC specialist, Document Control Coordinator, and two (2) quality control inspectors). In this position I was responsible for incoming raw material inspection, DMAIC process improvement implementation, site quality compliance for development and manufacture of liquid and powder concentrate for medical device dialysis equipment.Additional Responsibilities:(Site-level Management of Critical Quality Systems/Functions: - Oversight of) - Lead Corrective and Preventive Actions (CAPA) team - Document Control (of nearly 1000+ documents) - Records Management - Data Management - Maintenance of documentation and record keeping systems so as to insure integrity, accuracy, completeness and quality of documentation. - Administer product release by assuring DHR integrity, generation of release documentation, and updating product status data. - Equipment/Facilities record QA - Lead Internal Audit functions - Provide lean, six sigma, statistical process control, and root cause analysis training for the organization- Perform performance reviews and hire personnel as required -Site Deputy Management Representative-Coordinate and support FDA and BSI audits

Senior Quality EngineerInitially hired by Ashland Chemicals as a senior quality engineer responsible for quality improvement and optimization for the specialty chemical production division. The division was purchased by air Products in 2004. Additional Responsibilities:Responsible for facilitation of Internal Audit Team (ISO 9000:2000 and ISO 14000), Advanced Product Quality Planning Team (FMEAs, Control Plans, Flow Diagrams, and Risk Management Programs), Management Review Board (MRB), Statistical Process Control Team, and Corrective and Preventive Action Team (CAPA). -Developed annual schedule for the Internal Audit Teams -Developed SPC program for site -Tracked APQP Team Objectives to closure -Tracked and drove efficiency in the CAPA, SPC, APQP teams -Assumed responsibilities of Quality Manager when out of plant (deputy management rep)-Trained and directed team with quality tool application and planning Assist with facilitation of ISO BVQI registrar audits-Site Deputy Management RepresentativeAshland was purchased by Air Products (Same Position)

Abbott Park, Illinois, Us

Senior Quality EngineerProvided quality improvement, compliance, training, and equipment optimization support for the printed circuit board (PCB) shop. The printed circuit board shop provided PCBs for Abbott diagnostic medical devices.Additional Responsibilities:Responsible for facilitation of Internal Audit Team (ISO 13485), Management Review Board (MRB), Statistical Process Control Team, and Corrective and Preventive Action Team (CAPA) . -Develop annual schedule for the Internal Audit Teams -Develop SPC program for site -Provide SPC training for printed circuit board (PCB) shop staff-Track and drive efficiency in the CAPA, SPC, and nonconforming material teams -Train and directed team with quality tool application and planning-Prepare Management Review Presentation-Core Member and facilitator of Material Review Board (MRB) -Optimize equipment and systems utilizing six sigma and lean methodologies

Project Engineer (Site Project Engineer/ Project Manager)Responsible for site wide engineering projects that included equipment qualification, site expansion, site infrastructure and facilities, electrical projects, and HVAC. In addition, part of the site leadership team that provided over-site for Colgate Oral Pharmaceutical manufacturing Additional Responsibilities:Responsible for all capital projects; Project Management and status reporting of the projects. -Develop feasibility studies and conceptual designs -Develop scope and preliminary engineering to facilitate cost estimates and appropriations -Develop final engineering designs through engineering consultants and evaluated options -Develop required documentation (standard operating procedures) -Prepare equipment design specifications for equipment procurement; evaluated suppliers' proposals and engineering data -Document system operations, including description of operation and technical procedures -Lead start-up planning activities; lead the execution of the start-up plan -Provide primary interface to operating customers for designs, training, and start-up -Implementation of Statistical Process Control (SPC/DOE/FMEA/Control Plans/Flow Diagrams) - Conduct Design of Experiment on manufacturing equipment to reduce hazardous waste disposal costs and reduce cycle time Factory Activities - Conduct training of the proper use and maintenance of several pieces of equipment - Implement Continuous Flow Manufacturing (CFM) - Support team implementation of CFM strategies on manufacturing assembly lines

Process Engineer (Central Process Engineering)Responsible for defense contract multi-Missile factory process engineering projects that included equipment qualification, equipment optimization, SPC, and new product line configuration. Raytheon TI Systems was originally Texas Instruments but was acquired by Raytheon in 1999. Additional Responsibilities:Responsible for all multi-missile factory process engineering projects and status reporting of the projects. -Develop feasibility studies and conceptual designs -Develop scope and preliminary engineering to facilitate cost estimates and appropriations -Develop final engineering equipment designs through engineering consultants and evaluated options -Develop required documentation (standard operating procedures) -Prepare equipment design specifications for equipment procurement; evaluated suppliers' proposals and engineering data -Document system operations, including description of operation and technical procedures -Lead start-up planning activities; lead the execution of the start-up plan -Provide primary interface to operating customers for designs, training, and start-up -Implement Statistical Process Control (SPC/DOE/FMEA/Control Plans/Flow Diagrams) - Conduct Design of Experiment on equipment to identify optimized operating parameters/settings - Serve as lead for a Process Failure Mode Effects Analysis that reduced the defect rate for Multi-Missile Factory Hardware - Utilize Statistical Process Control on Multi-Missile Factory cleaning systems, conformal coating systems, soldering and rework technologies, and hardware defects - Formulate a Cleaning System Design of Experiment to find optimal settings for the equipment and reduce system cycle time - Prepare Surface Mount Rework Station Design of Experiment to reduce defect rate

Mba, Engineering/Operations Management

Bs Chemical Engineering, Chemical Engineering

Pre-Engineering

High School Diploma