Senior Quality Assurance Engineer

• Aug 2022 - Present

Quality Engineer 2

• Jan 2019 - Aug 2022

Responsible for various Quality Assurance functions for manufacturing development of medical devices in achievement of company goals. Design, develop, implement, and improve manufacturing processes to quality medical device products and systems. Essential Duties and Responsibilities: 1. Participates in the development of medical devices and components from design initiation through design transfer and by representing Quality Assurance for manufacturability in all design and development… Show more Responsible for various Quality Assurance functions for manufacturing development of medical devices in achievement of company goals. Design, develop, implement, and improve manufacturing processes to quality medical device products and systems. Essential Duties and Responsibilities: 1. Participates in the development of medical devices and components from design initiation through design transfer and by representing Quality Assurance for manufacturability in all design and development project teams. 2. Participates in all manufacturing activities to assure compliance of design specifications. 3. Leads development of quality plans of new product introductions based on design specifications, PFMEA, and control plans. 4. Works with design team and assist/provide feedback on design specifications and improvements. 5. Evaluates and develops effective and efficient methods of testing and inspection of products. 6. Utilizes problem solving tools and techniques and apply risk based approach to problem solving. 7. Determines necessity of testing and initiates testing by preparing test and inspection plans and identifying and obtaining required test fixtures and test/inspection instrumentation. 8. Initiates new projects and acts as the project leader for key initiatives, identifies best practices. 9. Performs quality trending and leads/supports process improvement initiatives. 10. Approves manufacturing product and process changes and assures the change management is controlled, adequate, and documented. 11. Responsible for MRB activities for assigned products, timely resolution of nonconformities, issuing and/or monitoring corrective actions associated with nonconformance and deviations. 12. Supports manufacturing suppliers with assistance in on-site resolution of quality and process related issues and corrective and preventive actions. Show less Responsible for various Quality Assurance functions for manufacturing development of medical devices in achievement of company goals. Design, develop, implement, and improve manufacturing processes to quality medical device products and systems. Essential Duties and Responsibilities: 1. Participates in the development of medical devices and components from design initiation through design transfer and by representing Quality Assurance for manufacturability in all design and development… Show more Responsible for various Quality Assurance functions for manufacturing development of medical devices in achievement of company goals. Design, develop, implement, and improve manufacturing processes to quality medical device products and systems. Essential Duties and Responsibilities: 1. Participates in the development of medical devices and components from design initiation through design transfer and by representing Quality Assurance for manufacturability in all design and development project teams. 2. Participates in all manufacturing activities to assure compliance of design specifications. 3. Leads development of quality plans of new product introductions based on design specifications, PFMEA, and control plans. 4. Works with design team and assist/provide feedback on design specifications and improvements. 5. Evaluates and develops effective and efficient methods of testing and inspection of products. 6. Utilizes problem solving tools and techniques and apply risk based approach to problem solving. 7. Determines necessity of testing and initiates testing by preparing test and inspection plans and identifying and obtaining required test fixtures and test/inspection instrumentation. 8. Initiates new projects and acts as the project leader for key initiatives, identifies best practices. 9. Performs quality trending and leads/supports process improvement initiatives. 10. Approves manufacturing product and process changes and assures the change management is controlled, adequate, and documented. 11. Responsible for MRB activities for assigned products, timely resolution of nonconformities, issuing and/or monitoring corrective actions associated with nonconformance and deviations. 12. Supports manufacturing suppliers with assistance in on-site resolution of quality and process related issues and corrective and preventive actions. Show less

R&D Engineer

• Mar 2018 - Dec 2018

Primarily responsible for the following core technical activities (but not limited to) in the Catheter Remediation Project at BD-CR BARD(Client): • RDL: Certified Engineer and Technician on various R&D Equipments such as Instron, Sprint, Hydraulic Burst/Leak, Heat Chambers, Gravity Flow etc. Perform tests on these various equipments for the remediation project. • Test Method identification: Identify appropriate test methods to be performed on the parts per ISO Standards . • Reports… Show more Primarily responsible for the following core technical activities (but not limited to) in the Catheter Remediation Project at BD-CR BARD(Client): • RDL: Certified Engineer and Technician on various R&D Equipments such as Instron, Sprint, Hydraulic Burst/Leak, Heat Chambers, Gravity Flow etc. Perform tests on these various equipments for the remediation project. • Test Method identification: Identify appropriate test methods to be performed on the parts per ISO Standards . • Reports, Protocols & Technical Writing: Document tests and results. Perform statistical analysis on the results using Minitab when needed. Write complete Protocols and Reports. Show less Primarily responsible for the following core technical activities (but not limited to) in the Catheter Remediation Project at BD-CR BARD(Client): • RDL: Certified Engineer and Technician on various R&D Equipments such as Instron, Sprint, Hydraulic Burst/Leak, Heat Chambers, Gravity Flow etc. Perform tests on these various equipments for the remediation project. • Test Method identification: Identify appropriate test methods to be performed on the parts per ISO Standards . • Reports… Show more Primarily responsible for the following core technical activities (but not limited to) in the Catheter Remediation Project at BD-CR BARD(Client): • RDL: Certified Engineer and Technician on various R&D Equipments such as Instron, Sprint, Hydraulic Burst/Leak, Heat Chambers, Gravity Flow etc. Perform tests on these various equipments for the remediation project. • Test Method identification: Identify appropriate test methods to be performed on the parts per ISO Standards . • Reports, Protocols & Technical Writing: Document tests and results. Perform statistical analysis on the results using Minitab when needed. Write complete Protocols and Reports. Show less

Manufacturing Engineer

• Jun 2016 - Mar 2018

Working as a Contractor through TCS. Primarily responsible for the following core developmental activities (but not limited to) in the 3D Printing COE at Johnson & Johnson(Client): • RDL: Perform R&D testing’s on 3D printed and metal coated plastic coupons, parts and prototypes. • Test Method identification: Identify appropriate test methods to be performed on the coupons and parts per ASTM Standards . • Engineering Study & Technical Writing: Document tests and results. Perform… Show more Working as a Contractor through TCS. Primarily responsible for the following core developmental activities (but not limited to) in the 3D Printing COE at Johnson & Johnson(Client): • RDL: Perform R&D testing’s on 3D printed and metal coated plastic coupons, parts and prototypes. • Test Method identification: Identify appropriate test methods to be performed on the coupons and parts per ASTM Standards . • Engineering Study & Technical Writing: Document tests and results. Perform statistical analysis on the results using Minitab when needed. Write complete Engineering Studies and also other technical documents, power point presentations (including Quarterly Reports), spreadsheets etc. • Project Management using TRL Process: Execute and drive Technology Readiness Level Tasks to completion for multiple projects using Project Co-ordination and Project Management Skills in order to achieve the desired TRL Level/Stage under the allocated time period. Show less Working as a Contractor through TCS. Primarily responsible for the following core developmental activities (but not limited to) in the 3D Printing COE at Johnson & Johnson(Client): • RDL: Perform R&D testing’s on 3D printed and metal coated plastic coupons, parts and prototypes. • Test Method identification: Identify appropriate test methods to be performed on the coupons and parts per ASTM Standards . • Engineering Study & Technical Writing: Document tests and results. Perform… Show more Working as a Contractor through TCS. Primarily responsible for the following core developmental activities (but not limited to) in the 3D Printing COE at Johnson & Johnson(Client): • RDL: Perform R&D testing’s on 3D printed and metal coated plastic coupons, parts and prototypes. • Test Method identification: Identify appropriate test methods to be performed on the coupons and parts per ASTM Standards . • Engineering Study & Technical Writing: Document tests and results. Perform statistical analysis on the results using Minitab when needed. Write complete Engineering Studies and also other technical documents, power point presentations (including Quarterly Reports), spreadsheets etc. • Project Management using TRL Process: Execute and drive Technology Readiness Level Tasks to completion for multiple projects using Project Co-ordination and Project Management Skills in order to achieve the desired TRL Level/Stage under the allocated time period. Show less

Quality/CAPA Engineer

• Dec 2014 - May 2016

Worked as a contractor through TCS. Responsible for support activities in the area of medical implants and devices at Zimmer Biomet, Inc (Client). Managed special projects along with providing management support to CMS, JDE, CAPA’s and other time-sensitive issues. Co-ordinated with different offshore teams for multiple projects (including remediation type projects) and was responsible for project setup and execution. Supported the Final Release Department and was a key player in the… Show more Worked as a contractor through TCS. Responsible for support activities in the area of medical implants and devices at Zimmer Biomet, Inc (Client). Managed special projects along with providing management support to CMS, JDE, CAPA’s and other time-sensitive issues. Co-ordinated with different offshore teams for multiple projects (including remediation type projects) and was responsible for project setup and execution. Supported the Final Release Department and was a key player in the development of process flowcharts, data analysis, process enhancements and document verification all done in accordance with the FDA Regulations – 21 CFR 820. Primarily responsible for the following core support activities (but not limited to): • CAPA: Develop timelines, investigation plans, conduct root cause analysis, update Enovia, and implement process improvements to address the CAPA. • Documentation: Implement changes to Zimmer Biomet procedures (SOP/GSOP) along with creating appropriate flowcharts and process flow charts. Verification and validation of documents for CAPA and CMS processes. Followed up by training the inspectors on the shop floor. • Continuous Improvement: On multiple occasions, suggested and implement software and technical improvements to reduce product turnaround time by eliminating Operator hardships. • 5S: Mark Final Release and other departmental areas with appropriate 5S colored tapes and certificates for safety, space management and proper work flow. • Manufacturing: Run various queries in JDE for special projects (Routing & BOM to make changes to the DHF’s and DMR’s). Enhanced the Flagging function in the apex database for Manufacturing to put product on hold. Assisted in designing the database such that Final Release is more accountable for each Red Flag. Show less Worked as a contractor through TCS. Responsible for support activities in the area of medical implants and devices at Zimmer Biomet, Inc (Client). Managed special projects along with providing management support to CMS, JDE, CAPA’s and other time-sensitive issues. Co-ordinated with different offshore teams for multiple projects (including remediation type projects) and was responsible for project setup and execution. Supported the Final Release Department and was a key player in the… Show more Worked as a contractor through TCS. Responsible for support activities in the area of medical implants and devices at Zimmer Biomet, Inc (Client). Managed special projects along with providing management support to CMS, JDE, CAPA’s and other time-sensitive issues. Co-ordinated with different offshore teams for multiple projects (including remediation type projects) and was responsible for project setup and execution. Supported the Final Release Department and was a key player in the development of process flowcharts, data analysis, process enhancements and document verification all done in accordance with the FDA Regulations – 21 CFR 820. Primarily responsible for the following core support activities (but not limited to): • CAPA: Develop timelines, investigation plans, conduct root cause analysis, update Enovia, and implement process improvements to address the CAPA. • Documentation: Implement changes to Zimmer Biomet procedures (SOP/GSOP) along with creating appropriate flowcharts and process flow charts. Verification and validation of documents for CAPA and CMS processes. Followed up by training the inspectors on the shop floor. • Continuous Improvement: On multiple occasions, suggested and implement software and technical improvements to reduce product turnaround time by eliminating Operator hardships. • 5S: Mark Final Release and other departmental areas with appropriate 5S colored tapes and certificates for safety, space management and proper work flow. • Manufacturing: Run various queries in JDE for special projects (Routing & BOM to make changes to the DHF’s and DMR’s). Enhanced the Flagging function in the apex database for Manufacturing to put product on hold. Assisted in designing the database such that Final Release is more accountable for each Red Flag. Show less