Sarahi G. Email and Phone Number

Provide quality engineering support to ensure the successful development of Medtronic medical device products; ensure design control requirements are met and products are developed and manufactured in accordance with applicable industry standards, regulatory requirements and customer requirements; navigate the complexities of quality systems in a regulated environment to include FDA QSR (Quality System Regulation) 21 CFR 820, ISO 9001, ISO 13485 and ISO14971; leverage DMAIC… Show more Provide quality engineering support to ensure the successful development of Medtronic medical device products; ensure design control requirements are met and products are developed and manufactured in accordance with applicable industry standards, regulatory requirements and customer requirements; navigate the complexities of quality systems in a regulated environment to include FDA QSR (Quality System Regulation) 21 CFR 820, ISO 9001, ISO 13485 and ISO14971; leverage DMAIC (Define/Measure/Analyze/Improve/Control) Methodology, 8D (8 disciplines problem solving), Corrective & Preventive Actions (CAPA), Good Manufacturing Practices (GMP), and Root cause analysis (RCA); coordinate verification and validation processes to include FMEA (Failure Mode and Effects Analysis), PFMEA (Process Failure Mode and Effects Analysis), and DFMEA (Design Failure Mode and Effects Analysis), methodical problem solving, and product design & manufacturing engineering; responsible for Design of Experiments (DOE), Statistical Process Control (SPC), Acceptance Sampling, Test Method Qualification (TMQ), Gage Repeatability & Reproducibility (Gage R&R), and Analysis of Variance (ANOVA); develop various protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ); responsible for various Corrective and Preventive Actions (CAPA) and adheres to Good Manufacturing Practices (GMP) statistical methodologies for data analysis and conclusions using advanced statistical software to include Minitab and JMP software. Ensures that corrective measures meet acceptable reliability standards and that documentation complies with requirements. Apply Degin Reliability Manufacturing tools during the qualification of the manufacturing processes. Create and maintain an outstanding relationship with suppliers. Show less

• Ensure that suppliers deliver quality parts, materials, and services, prevent defects that allow Medtronic to provide customers with the highest quality and reliable products.• Define component qualification strategy, partner with suppliers to develop qualification plan, report performance, and demonstrate release readiness. Define control plans to ensure appropriate acceptance activities.• Qualify suppliers according to company standards and may administer a Supplier Owned Quality… Show more • Ensure that suppliers deliver quality parts, materials, and services, prevent defects that allow Medtronic to provide customers with the highest quality and reliable products.• Define component qualification strategy, partner with suppliers to develop qualification plan, report performance, and demonstrate release readiness. Define control plans to ensure appropriate acceptance activities.• Qualify suppliers according to company standards and may administer a Supplier Owned Quality program in receiving inspection to ensure cost effectiveness.• Monitor parts through the manufacturing cycle and communicate then resolve supplier-related problems as they occur.• Evaluate suppliers' internal functions to assess their overall performance and provide feedback in assessment of their operation.• Provide technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts and implement strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance to applicable industry standards, regulatory requirements, and customer requirements.• Collaborate with R&D Engineers to advance device level design-build-test activities early and often in the NPD process Show less

∙ Train new and current coordinators on HR Service Center transaction process∙ Troubleshoot HR system errors to reduce the impact and increase the team’s efficiency ∙ Assist the RPA coordinator and serve as back-up∙ Lead system projects to improve the transaction process∙ Analyze root-cause to provide solutions on system and process issues resulting on decrease wasting time

∙ Managed job and positioned data entries for tenure-track faculty, university staff increasing the transaction accuracy ∙ Ensured compliance with University, State, Federal rules, I-9 & e-verify, FLSA, FMLA, resulting in decreasing liability∙ Interpreted and explained human resources policies, procedures, standards, or regulations to answer inquiries and provide personnel actions resulting in increased process accuracy and customer satisfaction

∙ Created and put in place the organization’s Chemical Control Safety Program resulting in improving the safety indicators by 20%∙ Worked with the company Board of Directors and committee to conduct AIB audits which yielded excellent audit results∙ Translated operational materials and interpreted (English- Spanish) as needed resulting in improved customer services by 35%∙ Entered the data into Boulder system on time to keep track of the services received for each customer to… Show more ∙ Created and put in place the organization’s Chemical Control Safety Program resulting in improving the safety indicators by 20%∙ Worked with the company Board of Directors and committee to conduct AIB audits which yielded excellent audit results∙ Translated operational materials and interpreted (English- Spanish) as needed resulting in improved customer services by 35%∙ Entered the data into Boulder system on time to keep track of the services received for each customer to decrease duplicate entries and increase the data accuracy by 15% Show less

∙ Conducted bilingual annual compliance training, environmental health, and safety programs∙ Conducted safety incident investigations and provide recommendations for corrective actions ∙ Assisted with other HR and related corporate communications that require translation into Spanish ∙ Served as a point of contact for external staffing partners regarding orientation, recruitment, health, and safety needs∙ Overseed the onboarding process, including employee benefits programs… Show more ∙ Conducted bilingual annual compliance training, environmental health, and safety programs∙ Conducted safety incident investigations and provide recommendations for corrective actions ∙ Assisted with other HR and related corporate communications that require translation into Spanish ∙ Served as a point of contact for external staffing partners regarding orientation, recruitment, health, and safety needs∙ Overseed the onboarding process, including employee benefits programs, for newly hired non-English speaking employees Show less

Led communication/ bilingual HR Program.• Conducted new employee onboarding and orientation for non- English speaking employees• Conducted benefits orientation in Spanish• Delivered annual compliance training and assist with other HR and corporate-related communication programs for non- English speaking employees• Partnered with HR Partners to respond to employee concerns when needed• Liaisoned with external staffing partners for orientation, training, recruitment, EH&S… Show more Led communication/ bilingual HR Program.• Conducted new employee onboarding and orientation for non- English speaking employees• Conducted benefits orientation in Spanish• Delivered annual compliance training and assist with other HR and corporate-related communication programs for non- English speaking employees• Partnered with HR Partners to respond to employee concerns when needed• Liaisoned with external staffing partners for orientation, training, recruitment, EH&S needs• Complete translations and facilities outsourcing of documents to ensure compliance and consistency with corporate policy and guideline updates• Act as a change agent and champion of diversity and inclusion EH&S Duties:• Delivered bilingual environmental, health, and safety programs for Longmont Site and be the primary resource for other sites when needed• Conducted new employee orientation and temporary agency employee orientation in Spanish• Conducted annual environmental, health, and safety training programs or acts as a translator for these programs to ensure understating and compliance• Translated EH&S standard operating procedures, safety team meeting minutes, and industrial hygiene sampling reports and communicate to affected personnel • Partnered with EH&S Director, EH&S Coordinator, and External Staffing Partners to promote safety culture and promptly respond to employee safety concerns.• Conducted safety incident investigations and communicate corrective actions recommendations. Show less

∙ Inspected prints to ensure quality standards were met, identified defects, and ensured quality issues were corrected resulting in a 30% decrease in rejected products∙ Conducted daily audits in all departments within the CDP division, ensured proper use of forms, processes, adherence to regulations, rejected products that did not meet quality standards and coached employees regarding quality standards and manufacturing processes resulting in decreased quality errors by 10%… Show more ∙ Inspected prints to ensure quality standards were met, identified defects, and ensured quality issues were corrected resulting in a 30% decrease in rejected products∙ Conducted daily audits in all departments within the CDP division, ensured proper use of forms, processes, adherence to regulations, rejected products that did not meet quality standards and coached employees regarding quality standards and manufacturing processes resulting in decreased quality errors by 10% annually∙ Implemented Lean manufacturing knowledge to boost the production process and improve the canvas quality resulting in reducing the wasted time by 5% on most production lines ∙ Utilized root-cause and “five whys” tools to provide solutions on manufactory processes, quality testing, and final products to reduce production errors and speed up delivery time by 10% Show less

∙ Standardized the production process to meet the ISO 9001 standards resulting in decreasing process errors by 20% ∙ Led the quality group on creating and maintaining the ISO 9001 and OSHA SOPs resulting in improving the product quality by 27% ∙ Planned the daily, weekly, and quarterly production flow to meet customer requirements on time, resulting in speed up the delivery time by 15% ∙ Applied Lean Manufacturing analysis to reduce waisted time on the production lines resulting in… Show more ∙ Standardized the production process to meet the ISO 9001 standards resulting in decreasing process errors by 20% ∙ Led the quality group on creating and maintaining the ISO 9001 and OSHA SOPs resulting in improving the product quality by 27% ∙ Planned the daily, weekly, and quarterly production flow to meet customer requirements on time, resulting in speed up the delivery time by 15% ∙ Applied Lean Manufacturing analysis to reduce waisted time on the production lines resulting in a 25% production increase∙ Analyzed decision trees, root-cause, and mind maps to provide inventory and production solutions resulting in a 15% increase in efficiency ∙ Coached employees to solve conflicts and cooperated with the HR investigation process increasing employees satisfaction by 10% Show less

Developed quality management system documents. • Developed and administered the ISO 9001:2000 process of Impresos Maracaya, c.a by leading manufacturing operations and commercial teams (about 30 people). • Applied problem-solving techniques, statistical process control tools, and statistic charts to solve quality and manufacturing problems. • Auditted the ISO 9001 process and recommended improvements in the following areas: Documents control and manufacturing process. • Establish a… Show more Developed quality management system documents. • Developed and administered the ISO 9001:2000 process of Impresos Maracaya, c.a by leading manufacturing operations and commercial teams (about 30 people). • Applied problem-solving techniques, statistical process control tools, and statistic charts to solve quality and manufacturing problems. • Auditted the ISO 9001 process and recommended improvements in the following areas: Documents control and manufacturing process. • Establish a quality manual. Show less

Tracked and solved customer complaints regarding quality issues.Applied problem-solving techniques and manufacturing problems.Created new ink formulations to improve the quality of flexographic ink.