Experience

ALCOR Scientific

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

• Project Manager

  • Dec 2022 - Present



DePuy Synthes

• United States
• Medical Device
• 700 & Above Employee

• Project Manager (Validation)

  • Dec 2020 - Dec 2022

• Supplier Quality Engineer

  • May 2020 - Nov 2020

  - Provide overall quality assurance leadership in the management of suppliers engaged in the production of Synthes products- Lead the Supplier PVE process with responsibility for deliverables and associated documentation- Review and develop IQ/OQ/PQ protocols by identifying inspection and test activities, special measuring and test equipment, appropriate statistical techniques, data collection methods, and sampling plans for establishing, controlling and verifying process stability/capability.- Responsible for verifying, reviewing, and submitting PPAP deliverables for contract manufacturers- Responsible for developing Incoming Inspection and First Article Inspection (FAI) documents- Participate in change control management and qualification of supplier process changes and supplier transfers programs- Ensure supplier process validation and approval in line with internal and regulatory requirements- Promote continuous improvement and Process Excellence activities within the Global Supply Chain- Collaborate with internal cross-functional team members and suppliers on timeline execution for SQE responsibilities - Liaise with internal stakeholders to ensure any supplier-based decisions are understood and accepted at site level



BD

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

• Quality Engineer

  • Dec 2018 - May 2020

  - Manage completion of assigned complaint investigation files related to Urological and Critical Care (BDI-UCC) products, both capital equipment products and single-use - Perform investigations in compliance to FDA 21 CFR Part 820, 21 CFR Part 803 (MDR), ISO 13485, IEC 60601, and ISO 14971 regulations and work with the manufacturing sites or external suppliers, where necessary - Communicate and coordinate with multifunctional groups (clinical, field assurance, PMS and risk management) to ensure timelines and deliverables - Provide support to MDR and Closure teams in relation to adverse events reporting, trending and analysis - Review Device History Records (DHR) and Incoming Quality Control (IQC) records for any non-conformities, rejects or discrepancies pertaining to the complaint investigations - Review QA, ISO and other audit reports of suppliers subject to FDA regulations to assist with identification of risks and opportunities - Initiate engineering change projects (ECO’s, ECR’s and ECN’s) based on failures identified during complaint investigations and history records review - Coordinate with suppliers’ counterparts in addressing supplier-related adverse events, initiating SCAR/CAPA and ensuring timely implementation / effectiveness of the action plans



Zimmer Biomet

• Warsaw, Indiana

• Quality Engineer

  • Oct 2017 - Nov 2018

  - Act as Lead on assigned Corrective and Preventive Actions (CAPA) to fix product/process Non-Conformances and close CAPA’s as well as containment activities within timelines - Responsible for out of tolerance assessment, product/process evaluation & improvement for quality control and conducting initial investigation to address the open issues - Document and process Non-Conformance Reports for issue evaluation. Perform risk analysis and identify root cause for the Non-Conformances. Assist suppliers in identifying root causes for the Non-Conformances. - Apply principles of Lean Manufacturing, Six Sigma, DRM in day-to-day activities - Responsible for Design Verification and Validation planning & execution, statistical analysis. Work cross-functionally to perform root-cause analysis, investigation & resolution activities - Perform gap assessments and revise existing Design History Files (DHF) which is inclusive of all Design Control, Risk Management and Usability Engineering File records - Ensure DHF content completion, integrity, and regulatory & standards compliance - Establish Use Scenarios, Task Analyses, and Usability Risk Analyses for shoulder stems and fracture stems in collaboration with development engineers conforming to Usability Engineering standards ISO 14971:2012, and IEC 62366 - Responsible for first article inspection, incoming and in process inspections and lot release testing, including sampling strategies and test methods - Identify and implement effective process control systems to support the development and qualification of products to meet or exceed internal and external requirements



AFCONS Infrastructure Limited - A Shapoorji Pallonji Group Company

• India
• Construction
• 700 & Above Employee

• Procurement Engineer

  • Oct 2012 - Aug 2015

  Major Infrastructure Projects: Metro Rail Projects in Delhi, Kolkata & Chennai (India), Arcelor Mittal Iron Ore Facilities (Liberia, West Africa), Agra-Lucknow Greenfield Expressway Project (India), Chenab Railway Bridge Project (India) • Procurement of Consumables, Minor Assets & Spare Parts (Oct 2012 – Mar 2014) • Procurement of Capital Equipment (Capex) and all kinds of Major Assets (Apr 2014 – July 2015) - Work with the lead procurement manager and all relevant business unit stakeholders to drive sourcing events from requirements gathering through sourcing and contract execution - For every new project, get the initial stakeholders together to understand the scope and objectives for the procurement, and to discuss high level expectations / milestones for the project - Ensure that all relevant stakeholder groups have been identified, and that they are engaged at appropriate times throughout the procurement process - Collaborate with core project teams to prepare detailed Gantt charts and align the procurement plans accordingly - Recognize capable vendors, obtain competitive quotations, and conduct detailed cost analysis / technical analysis with Plant & Equipment Engineers - Develop and maintain a supply base that builds long term strategic relationships with key vendors that provide AFCONS with a competitive advantage within the infrastructure sector - Deliver an effective project management service for a number of strategic sourcing & procurement initiatives - Ensure procurement projects are planned and executed effectively by actively expediting for timely execution of purchase orders and ensuring minimum downtime at project sites - Participate in supplier assessments, product inspections, and equipment commissioning with Plant & Equipment Engineers - Analyze existing project management methods to promote effective operations through standardization, improvement, simplification, discontinuance, or other methods