BACKGROUND SUMMARY:

Quality Project Manager with extensive experience in manufacturing and broad background in implementing and managing QMS compliant to FDA CFR 820, ISO 13485/9001 and international regulatory standards, continuous improvement, design and process V&V, problem solving, CAPA, suppliers’ management, control and development in medical device and manufacturing Industry. PMI Certified PMP and ASQ Certified Six Sigma Black Belt and Certified Quality Engineer.

DEMONSTRATED SKILLS AND S IN THE FOLLOWING:

Project Management

APQP and PPAP Implementation

Lean Six Sigma Project Implementation

FDA & ISO 13485 Procedures Implementation

Supplier Development & Improvement

. Process/Product Validation & Verification (IQ/OQ/PQ)

NCR, CAPA, Problem solving, report writing

QMS Process/ Product Audit (ISO/FDA/MDD)

Process Development and Continuous Improvement

Supplier Assessment and Capability Analysis

EMPLOYMENT HISTORY:

Confidential

Supplier Quality Leader/Manager

Responsibilities:

• Supported the Strategic initiatives and projects from purchasing control prospective and ensure availability of right resources and successful execution of task according to project plan.
• Partner with R&D, Operations and Procurement personnel to proactively engineer quality and ensure compliance for raw materials, components, finished products from suppliers
• Develop and support regulatory compliance gaps at suppliers, including supplier quality system and process development activities
• Manage additions/deletions/changes to the status of suppliers on the Approved Supplier List, including supplier master file records
• Ensure raw materials/components/products at supplier(s) are released from supplier(s) to Confidential according to the agreed requirements
• Daily management support for production planning, forecasting and component availability for operations to build required systems.
• Perform 3rd party product compatibility risk assessments in partnership with R&D and Market Procurement
• Drive quality and compliance development and ensure all the functional KPIs are on target.
• Coach and Mentor Jr. Staff.

Confidential, Lake Zurich, IL

Project Manager - Quality System and Continuous Improvement

Responsibilities:

• Responsible for overseeing the project work for the mitigation of quality system and compliance issue, CAPA and continuous improvement initiatives.
• Manage execution of project plan, project documentation, change control and cross functional team meeting to ensure timely execution and completion of project activities.
• Create and report project status update and escalate the issue to management for timely resolution.

Principal Quality Engineer

Confidential

Responsibilities:

• Responsible for managing the NPD projects for newly established Arthroscopy cell.
• Develop and lead validation strategies (IQ/OQ/PQ), document validation and inspection plans, protocols and final reports.
• Establish Master Validation Plan (MVP) for new equipment included manual and auto laser welders, laser cutter, Swiss and multi-swiss machine centers,
• Wire and Sinker EDM, Electro polish cleaning system, induction and over molding.
• Develop risk management strategies (FMEA) for new processes and subsequent control plans.
• Developed inspection strategies and completed TMV of new measuring equipment and test methods.
• Provides project direction, coaching, teaching, and mentoring QEs and technical personnel.
• Provide Project update and issue escalation to Management.
• Manage a team of two exempt QE, one rotational engineer and two non-exempt QC inspectors for NPI validation and inspection support.
• Manages external suppliers quality for new product launch.
• Led process validation activities of newly established arthroscopy cell which included 3 multi-Swiss, 7 Swiss, 2 manual and one auto laser welders, laser cutter, knurling and 3 WEMD and a Sinker EMD, Induction molding and Electro polish system containing the qualification of 26 SKUs and around 64 components with planned revenue of $25M in 2016.
• Led and approved the TMV of various measuring equipment including the vision system (Micro-Vu) programming for edgeform inspection which reduced the inspection time from 15 min/pc to 2 min/pc.
• Established the Infinity QS inspection method on various workstations, which reduced the human error and provided real time inspection data and product quality control.
• Established and approved the inspection and control plan for new products/components.
• Led plant wise NCR reduction project with target to reduce 10% NCR by end 2016.
• Worked with cross function team for the execution of validation of new process and product launch.

Confidential, Lake Forest, IL

Project Manager - Quality Systems & Operations

Responsibilities:

• Responsible to manage global quality initiatives to strengthen the Quality Systems, including remediation and enhancement of supplier quality processes and procedures.
• Led multi-functional project team and successfully executed assigned quality initiatives including engaging, influencing and coordinating all functions involved in the project.
• Formulated detailed project plan, milestones and deliverables as well as project budget and resources and hold team accountable for achieving the plan.
• Identified potential risks and mitigated proactively by recommending solutions.
• Track and report project progress to senior leadership and project sponsor and timely escalated issues to senior management for resolution and project success.
• Designed Supplier PPAP program that applied to both device and Pharma businesses which become a cultural shift at Confidential and implemented supplier PPAP to 13 Confidential manufacturing sites.
• Trained internal and external suppliers on PPAP by conducting various 2-3 days Workshops.
• Developed the strategy to optimize and/or eliminated various local site level ASL by establishing One Global ASL used by all Confidential sites.
• Rationalized ASL with target to reduce 10% supplier base in 2014. Result achieved with 20% reduction of supplier base and bring cost saving of around $400,000 in audits and supplier management.
• Successfully conducted Kaizen event to optimize and simplify supplier qualification process.
• Established Supplier Quality Manual that applies for both Device and Pharmaceutical businesses.
• Developed and implemented Supplier Program that optimizes supplier base and reduce incoming quality inspection.
• Facilitated Kaizen event to streamline & optimize SCN process across various functions and manufacturing sites.

Confidential, Waukesha, WI

Lead Supplier Quality Engineer

Responsibilities:

• Responsible for driving exceptional product quality for the patient, customer value beyond expectations, regulatory assurance and compliance for newly acquired Vital Signs Devices (VSD) business. This was key technical leadership position, affecting part quality for both installed base and NPI parts for Vital Signs business. VSD provides single patient use disposable products like airway management & anesthesia breathing circuits, HCH filters, masks, EBM bags, tubes etc.
• Major responsibilities included but not limited to maintaining supplier base (ASL), supplier selection, qualification and monitoring, negotiation of supplier quality requirements contracts, product complaint and recalls, CAPA, SCARs, Change control (SCR, SCN), Audits planning, PQP and early supplier engagements for NPIs and Design Transfers, presentation of supplier quality metrics on quarterly QMRs, trending metrics etc.
• Work with all business functional departments and ensure suppliers are in compliant and meet GEHC procedures and other regulatory requirements.
• Led the QMS Integration project of newly acquired business (VSD) and established a solid foundation of quality and compliance integrated with Confidential QMS. New supplier base reevaluated and integrated into GEHC Global procedures and approved suppliers list.
• Developed more lean and effective supplier base for VSD business by consolidating suppliers from (25% reduction) where business did not make strategic sense.
• Led the sourcing and engineering team for design output classification of purchased products and categorization of supplier base per GEHC global procedures and compliance requirements.
• Remediated 26 conditionally qualified suppliers either developed to fully qualified or exited to mitigate business risk.
• Implemented SCAR escalation process and SCAR guidance tool for suppliers by leading special CI project, and enhanced quality and content of SCARs and improved response and % on-time from 50% in % in Dec 2012.
• Led and successfully implemented CAPA and eliminated the historical chronic product complaints, reduced the number of complaints to zero in 2012 compared to 10 in 2010 and 16 in 2011 and significantly increased the revenue in 2012.
• Established and successfully implemented supplier monitoring process in the absence of systematic process at newly acquired business which helped aligned and integrated with Global GEHC Monitoring process.
• Successfully supported Purchasing Controls during multiple FDA inspections and other internal and external audits with zero findings.
• Lead a continuous improvement project and introduced a Risk based audit tool that reduced the unnecessary annual supplier audits by 30% and reduces the cost of quality significantly.

Confidential, South Milwaukee, WI

Sr. Quality System Engineer

Responsibilities:

• Managed the Operations and Suppliers product quality to ensure the conformance of process and product requirements, monitor and evaluate KPIs to improve FPY and OTD.
• Managed non-conforming material through NCMR, MRB, CAR/SCAR process, Root Cause Analysis, 8D/5Why Corrective Action, customer complaints, inventory adjustments, FMEA, and PQPs.
• Conducted internal/external audits to monitor QMS and determine overall effectiveness.
• Developed and presented quality metrics and Pareto charts to monthly executive meetings.
• Implemented Six Sigma project that resolved historical issue of $170,000 value pedestal hoist for shovel that was causing extensive rework cost and time, utilized brainstorming, DMAIC and other project management tools and saved approximately $80,000 annually and improved on-time delivery.
• Successfully designed and implemented APQP and PPAP process best suited for mining industry and trained the internal and external suppliers.
• Developed suppliers and trained them on tools including PFD, PFMEA, Control Plan, ISIR, 5 Why and 8D analysis, reducing incoming inspection by 25%, NCR rate 15%, and improving on-time delivery of suppliers to 95% between year 2008 and 2009 .
• Led the implementation of a new supplier assessment/audit system to conduct Quality System Audit and Capability Analysis. Key features of new tool included objectivity, scoring system, graphical representation of strong and weak areas, identification of improvement areas and assessment of welding, casting, heat treating and other special processes.
• Value Stream the current state and future state of Supplier Approval Process and implemented changes to achieve future state, reducing expected time for supplier approval from 29 days to 15 days.
• Developed and documented a procedure that standardized the inspection requirements for purchased complete and sub-contracted fabricated, welded and machined components to increase FTY.
• Member of team that implemented lean manufacturing throughout the facility by utilizing 5S, Standard Work, VSM, pull and Kanban system, Kaizen events, and other lean tools.

Confidential, Riverdale, IL

Manufacturing/Quality Engineer

Responsibilities:

• Designed and redesigned mechanical drawings and converted mechanical to manufacturing drawings using AutoCAD 2002 and Pro Engineering.
• Created routing, traveler & SOP to define work scope.
• Supervise and maintain final inspection process.
• Investigate and response customer complaints.
• Utilized various SPC control charts to evaluate process capabilities, reducing variation and improving process and product quality.
• Successfully resolved numerous quality issues utilizing 8D analysis, 5Why’s, Pareto Analysis and established process FMEA and related Control Plans.
• Standardized the work instruction for roll refurbishing projects & trained employees on new SOP.
• Enhanced product drawings by implementing Geometric Dimension & Tolerance (GD&T) which improved product quality.