Experience

Surgical Technologies Inc

• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee

• • Jan 2020 - Present

  Manage sterilization program, test labs, and related activities:• Schedule and coordinate sterilization validations, re-validations, dose audits, lab test samples, etc. necessary to ensure the sterilization process remains in control and conforms to the customer and regulatory requirements. Maintain effectiveness of Quality Management System and compliance with ISO/FDA regulations:• Demonstrate knowledge and competency of all applicable internal and external quality management system requirements and standards via training and certification records. • Collect performance data and perform trend analysis to demonstrate the effectiveness of the quality management system and provide regular reports to management. • Host regulatory and customer quality audits. • Assist with maintaining regulatory certifications, registrations, and licenses. • Monitor manufacturing activities to ensure quality policy and quality procedures are implemented, associates are trained and system is being followed.Ensure the effectiveness of quality control acceptance and release activities:• Define quality control sampling plans using sound statistical methods that ensure the confidence and reliability levels required by the customer and per the risk analysis.• Ensure inspection test and measurement equipment/techniques are calibrated and capable to produce repeatable/reliable data to ensure conformance to specifications.• Ensure inspection plans are adequate to receive and accept components and materials per defined acceptance criteria for medical device/drug products. • Ensure quality records are reviewed and adequate to certify that products conform to customer and regulatory requirements before releasing them for shipment.Lead corrective action, nonconformance and compliant investigations:• Oversee corrective and preventive (CAPA) activities, nonconformance (NCMR) and complaint investigations. Show less

• • Oct 2018 - Jan 2020



CONMED Corporation

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• • Dec 2015 - May 2018

  • Responsible of quality assurance on the Manufacturing of disposable medical devices. Such as ground pads, skin staplers, cleaning brushes for endoscopies, electrodes (cut & coag), irrigation set, hose extrusion for irrigation set. Tube extrusion single, double, triple lumen. Packaging for sterile and non-sterile products• Responsible of the quality on the Manufacturing of electrical and electronic medical devices. Such as camera controllers for endoscopy, light sources, irrigation pumps, energy generators, drive systems (for controlling surgery tools) and cables for high definition cameras.• Coordinate the activities of 7 quality engineers who are in charge of the quality assurance of the manufacturing process.• Coordinate the activities of three quality supervisors (18 quality inspectors) who are in charge of the quality assurance of the manufacturing process.• Coordinate projects assigned to engineers and supervisors following 6 sigma methodologies.• Deal with audits from BSI (ISO 13485),FDA mock audit, JPAL, COESPRIS, KFDA, UL, INMETRO (Brazil).• CAPAS, NCR’s, ship holds, SCAR’s• Risk Analysis (severity vs. occurrence), HHE, FMEA (patient oriented.• Verifying/approving installation qualification IQ, operational qualification OQ, performance qualification PQ, Test method validation TMV. High lights:• Reduction of MRB material from $1,000,000 to less than 100,000.• Reduction from 3 digits NCR (non-conformance report) to 1 digit. Closed more than 80%.• Manager performance evaluation of 4.8. (Highest score 5) from employees. Show less

• • Jun 2014 - Dec 2016

  - Responsible of quality assurance on the Manufacturing of electrical and electronic medical devices. Such as camera controllers for endoscopy, light sources, irrigation pumps, energy generators, drive systems (for controlling surgery tools) and cables for high definition cameras. • Coordinate the activities of two quality engineers (and one technician and one quality inspector)who are in charge of the quality assurance of the manufacturing process. • Coordinate activities of one new product introduction engineer (and one quality technician). Who is responsible of the proper transferring and/or new products from the quality stand point. This during Centennial CO. transference. • Part of the quality assurance is to verify the correct validation of the process. Verifying/approving installation qualification IQ, operational qualification OQ, performance qualification PQ, Test method validation TMV. • Coordinate activities of one supplier quality engineer (and one technician). • Responsible of CAPA. • Deal with audits from BSI (ISO 13485),FDA mock audit, JPAL, COESPRIS, KFDA, UL, INMETRO (Brazil). • Deal with ship holds due to quality issues. High lights:• Coordinator performance evaluation of 4.5 (Highest score 5) from employees.• Part of hi pot (high potential) employees.• Transference done successfully Show less

• • Oct 2012 - Jun 2014

  - • Verifying/approving installation qualification IQ, operational qualification OQ, performance qualification PQ, Test method validation TMV. • Following and closure of non conformance report (NCR). • Responsible for answering SCAR generated by our customer. • Responsible for releasing material, reviewing device history record (DHR). • Generate and sustain component inspection plan, failure mode effect analysis and control plan. • Responsible of material returned (RMA). Analysis and disposition. • Deal with Underwriters Laboratories Inc (UL) inspections and Intertek. • Assure compliance in production process with ISO 13485. • FMEA and CP owner. Severity oriented to patient. • Responsible for keep manufacturing process aligned with product specifications. High lights:• Part of hi pot (high potential) employees. Show less



Electrical Components International

• United States
• Appliances, Electrical, and Electronics Manufacturing
• 700 & Above Employee

• Quality Assurance Engineer

  • Jul 2009 - Oct 2012

  •• Assure that product transferences from China to Mexico exceed the customer quality requirements. • To determinate and document all improvement opportunities during NPI planning. • Follow up and participation on the APQP activities in all steps in order to achieve a successful implementation. Turn in all the process with the necessarily controls in order to get an autonomous process. • Answer of SCAR’s from customer using 8D’s, 5 whys, cause and effect diagram • Responsible for leading, implementing and maintaining the corrective actions requested in production floor and customers. High lights: • Reduction of ppm’s from 1500 to 150 on Mabe part numbers. Show less



Emerson

• United States
• Industrial Machinery Manufacturing
• 700 & Above Employee

• Field Service Engineer

  • Apr 2001 - Jul 2009

  • Analysis responsible of the customer rejects (line and field) in order to find failure, root cause and generate corrective action on electronic and mechanical controls. • Deal with suppliers for getting failure analysis, corrective actions, new parts development and/or improvement. • Quality audits to suppliers when opportunities of improvement are detected such as poor service and quality. • Responsible of 2 technicians and 3 interns. • Responsible of reliability test on several products using Espec chambers and appliances. • Fabrication of reliability test fixtures and reliability test wire harnesses. • Visit customers on monthly basis (customer: ISE, Whirlpool/Maytag, and B/S/H/ Home Appliances Corporation and Electrolux) in order to identify and eliminate quality issues. • Program training to our customers on the usage of the test equipment and the correct handling of our products, basically ESD. • Resident engineer for new product launch in USA. • Provide corrective actions (8 disciplines reports) to reduce or eliminate problems at customer locations. • Update of Control plan, FMEA’s, flow diagram, standard time, map process, visual aids, warning aids, DCO for complying corrective actions. • Lead a monthly Scorecard review with customer, manufacturing, design and sales groups, to review PPM rates, quality issues and corrective actions. • Supervise the corrective action implementation (8D report must be fulfilled). • Six sigma tools used to reduce PPM with customers (PFMEA, Gage R&R, DOE, cause effect diagrams, SPC, etc.). Show less