Anurag Pandey
Quality Assurance Professional
Faridabad
Summary
Certified Six Sigma Black Belt professional for over 10+ years of proficient in Quality, Manufacturing, Supplier Development & Upgradation, TPM, and thrive in a dynamic, challenging and fast-paced work environment with knowledge of Low-Cost Automation & Continuous improvement and ensuring optimal utilization of resources.
Overview
11
11
years of professional experience
6
6
years of post-secondary education
2
2
Languages
Work History
Sr. Engineer - SQA
Qure Medical Devices
06.2022 - Current
- Company Overview: Qure Medical Devices provides a full range of products and services to help OEMs bring medical devices to market specialized in silicone and other elastomeric, manufacturing a broad array of high-performance single-use devices as well as precision components and subassemblies. Major customers are Ethicon (Johnson & Johnson Company), Medtronic, B Braun, Cook Medical, Intermed, Medline, Cardinovum, MedAlliance.
- Driving Supplier selection and evaluation process of new and existing suppliers.
- Executing PPAP Documentation, quality agreements and performing audits as part of initial assessment and ongoing management of Supplier relationships; ensure compliance with relevant quality system regulations.
- Acting as primary quality contact with suppliers, working with them to solve issues that arise and recommend improvements.
- Representing Supplier Quality on product development and participate in the selection of material suppliers.
- Completing investigations of nonconforming materials to understand the root cause of failure driving corrective actions internally and externally with suppliers.
- Monitoring supplier quality performance metrics and drive resulting corrective/preventive actions determined to be necessary.
- Actively helping organization to maintain and improve a Quality System compliant with FDA regulations and ISO 13485 (e.g., training documents, procedures, work instructions, specifications, labeling).
- Assisting in any external regulatory audits (FDA, notified body) in support of the QMS.
- Interfacing with internal functions, such as Design Assurance, Global Engineering, and R&D, on new product development projects and significant changes related to supplier processes.
- Supporting development and maintenance of Design History File (DHF) and Technical Files for QMD owned design and private label products.
- Evaluating suppliers' internal functions to assess their overall performance and provide feedback through quality tools such as 8D process, cause, and effect diagrams, FMEA, SPC, DOE, and GR&R.
- Executing supplier management plans to improve supplier and product performance, including site visits to resolve product performance concerns.
- Supporting the development of an auditing schedule to ensure that designated suppliers are audited on a regular basis and quality standards (ISO procedures) are met.
- Participating in design reviews for product and/or components and assures that suppliers are involved early in the process.
- Utilizing project management skills to lead root cause investigations and quality improvement initiatives with key suppliers. Collaborating with cross-functional technical community (Manufacturing, Engineering and R&D) and suppliers, whilst communicating progress to all levels of the organization with a focus on business impact.
- Identifying and implement cost savings opportunities by partnering with Operations and Engineering.
- Mentoring and training others on subject matters related to the certified quality engineering body of knowledge and manufacturing principles and practices.
- Qure Medical Devices provides a full range of products and services to help OEMs bring medical devices to market specialized in silicone and other elastomeric, manufacturing a broad array of high-performance single-use devices as well as precision components and subassemblies. Major customers are Ethicon (Johnson & Johnson Company), Medtronic, B Braun, Cook Medical, Intermed, Medline, Cardinovum, MedAlliance.
Engineer - SQA, QMS & Manufacturing excellence
Sanoh India Private Limited
10.2018 - 10.2022
- Company Overview: Sanoh India Limited have 8 manufacturing plants & in India. Sanoh India is involved in sheet metal parts, welded assembly, Pipe components and heavy fabrication work. It is a major supplier for two wheelers & four wheelers in Automobile sector. Its main Customers are MSIL, HCIL, JCB, TATA Motors, HMSIL, Mahindra and Mahindra, Ashok Leyland, Renault-Nissan (RNAIPL).
- Zero Defect Drive at Customer & Supplier End.
- Conduct Vendor Process audits for verification of compliance to system Implement actions & system audit Analysis & resolution of field issues.
- Responsible for Process Improvement through PFMEA Audits.
- Ensure timely Response of suppliers in case of defective parts receive.
- To support all plants to resolve critical quality issues.
- Drive continuous improvement activities, focus on prevention rather than detection.
- Conducting Supplier Initial Assessment for supplier Selection.
- Manage, review, monitor and improve Supplier/Customer quality Performance.
- Responsible For Supplier Up gradation as per MSIL-VSA & HMSI QAV-1&2.
- Responsible to implement the SOC/REACH/ROHS/HAZMAT compliance at Supplier ends.
- Taking Initiatives as per Industrial Revaluation as per IR-4.0.
- Actively Participated & Monitoring the Business Excellence activity like as Reduction in manpower through line balancing, process optimization, Consumable Cost Saving, Power & Fuel Cost reductions.
- Responsible for Control & updating of documents by review for adequacy.
- Coordinate with Purchase & Engineering team for Making process Robust.
- Responsible for planning and executing quarterly internal audits of 8 plants and regular follow up for NC closure along with verification of corrective action taken.
- Responsible for in-house training of kaizen, Poka-yoke, 4M Change & Procedure adherence.
- Controlling all in-process inspection in Heavy press shop & weld shop.
- Plan & execute the fixture calibration used in weld shop.
- Plan & execute the welding penetration plan.
- Inspection of all Press shop & weld shop operation as per operating procedure.
- Plan & execute the Process audit as per plan in Press shop & weld shop.
- Verification of properties on final product through Destructive and Non- Destructive Testing such as Torque test, Tensile strength Testing machine, Compression Strength Testing (Force Gauge), Flexon Strength Testing, Cutting Strength test, Hardness Testers.
- Daily red bin analysis.
- Handling and use of different measuring instrument used in an incoming quality department like (Callipers, height gauge, Micrometre, Mustimeter, Go-no-go gauges, Pin Gauge) Giving UD (Usage decision) in SAP for regular activity.
- Identify the Kaizen in In-process on shop floor for process improvement.
- Responsible for CAPA submission against the defect punch in customer complaint.
- Sanoh India Limited have 8 manufacturing plants & in India. Sanoh India is involved in sheet metal parts, welded assembly, Pipe components and heavy fabrication work. It is a major supplier for two wheelers & four wheelers in Automobile sector. Its main Customers are MSIL, HCIL, JCB, TATA Motors, HMSIL, Mahindra and Mahindra, Ashok Leyland, Renault-Nissan (RNAIPL).
Engineer - SQA/QA
Sadhu Forging
01.2017 - 09.2018
- Company Overview: Sadhu Forging has 4 units in India dedicated for automobile section with expertise in engineering and design, diemaking, forging, heat-treatment and machining. With in-house services from start to finish, Sadhu Forging meets demanding schedules as well as oversee all development and production while controlling costs for customers: Eicher, Escort, Mahindra Rise, Swaraj, Tata, Yamaha.
- Execute supplier up-gradation plan v/s actual.
- Conduct the audit & close the NC's during supplier QMS/process/product audit.
- Face audit (Internal + customer +IATF/16949).
- Incoming inspection as per AQL level.
- Identification of DOL parts.
- Audits & approval of DOL Documentation of assessment, PPAP approval & DOL approval.
- New/existing supplier assessment for quality, cost, capability.
- New part supplier PPAP follow up & review.
- Settlement with dealer/distributor for warranty claim issues.
- Warranty claim analysis for O.E.M & Aftermarket Analysis.
- Closer of NCs from external/internal audits.
- Ensure PPAP should be submitted by supplier as per PPAP submission check sheet.
- Arrange Monthly Worst supplier meeting with top management.
- Driving supplier improvement by using vendor score cards, supplier audit score.
- Process improvement plans at supplier ends.
- Delivering results as measured by key metrics, such as supplier yield, warranty rates.
- Develop & validate the required testing & verification system at vendor ends.
- CAPA submission by supplier for line rejection & verification audits at supplier end.
- Publishing action plans against high rejection component.
- Supplier training for product quality, manufacturing, waste reductions.
- Sadhu Forging has 4 units in India dedicated for automobile section with expertise in engineering and design, diemaking, forging, heat-treatment and machining. With in-house services from start to finish, Sadhu Forging meets demanding schedules as well as oversee all development and production while controlling costs for customers: Eicher, Escort, Mahindra Rise, Swaraj, Tata, Yamaha.
Engineer - QA/Customer Complaint
Genus Electrotech Limited
06.2014 - 09.2016
- Job set up of part as per operation standard.
- Patrolling inspection as per control plan.
- Online SPC for critical specification.
- Red bin analysis for reduction for in house rejection PPM.
- Jigs & fixture calibration as per plan.
- Plan & execute the Process audit as per plan in Press shop & weld shop.
- Identify the Kaizen in process on shop floor for process improvement.
- Responsible for CAPA submission against the defect punch in customer complaint.
- Responsible for ICA at customer end & In house end.
- Responsible for ICA at customer end & Vendor end.
Education
B.Tech. - Mechanical Engineering
West Bengal University of Technology
01.2010 - 01.2014
12th - undefined
Kendriya Vidyalaya
01.2008 - 01.2009
10th - undefined
Kendriya Vidyalaya
01.2006 - 01.2007
Skills
Certified Six Sigma expert
Certified auditor for VSA systems
Quality system management
Audit process
Product quality review
Compliance assessment
Technical project management
5S methodology implementation
Continuous improvement initiatives
Supplier evaluation
Supplier performance enhancement
Supplier development
ISO 9001:2015 internal auditor certification
IATF 16949:2016 certified internal auditor
ISO 14001:2015 internal auditor certification
ISO 45001:2018 internal auditor certification
Manufacturing of medical devices
Experience with 21 CFR Part 820 standards
ISO 13485 compliance
Knowledge of EU medical device regulation
Customer audit management
Management meeting data analysis and preparation
PFMEA facilitation and documentation
PPAP compliance management
Advanced product quality planning
Proficient in MSA compliance
Data-driven process improvement
Proficient in DMAIC process
Quality assurance proficiency
8D analysis proficiency
Process improvement methodology
Accomplishments
- Vascular RM inventory storage enhancement from 1.8 Cr INR to ≥3.6 Cr INR.
- Destination transportation charges to be reduced for import shipments.
- Reduce Beverage's consumption cost by 10% from the baseline.
- Reducing the average issuance time of maintenance tools and spares from 60 minutes to ≤ 40 minutes.
- Reduction in In-house paper consumption by 10 % from the baseline.
- Reduction material stock for packaging cartons and labels of Domestic suppliers by 50 % from the baseline.
- Localization of labels and packaging cartons to reduce the freight cost and lead time of receiving the shipments.
- Balloon Catheter In process rejection reduction from 8.17 % to < 6 %, Financial Impact = 30 Lakhs INR $/year=40540$
- CRB Catheter Injection Molding In process rejection reduction from 7.5% to 5.8%.
- Energy consumption of Arthesys India plant reduction by 10% from 15543K INR to 13989KINR (44.2INR/Pc to 40INR/pc).
- 20 % Reduction of Outgoing DPPM rejection from 10584 in Bare sub-assembly line.
- To Eliminate the rejection of CRB catheter short length from 1.27% to 0%.
- To reduce the Fiber rejection from 16.4 % to 13.1 % (20% reduction).
Personal Details
- Father's Name: Shri Arun Kumar Pandey
- Date of Birth: 03/04/1991
- Nationality: Indian
- Marital Status: Married
Proficient In
- Certified Six Sigma Black Belt
- Certified VSA System Auditor at T2 Vendor
- Quality system procedure.
- Process, Product, System audit.
- TPM, 5S & Kaizen Activities.
- Supplier Audit, Development & Upgradation.
- Certified Internal Auditor in ISO 9001:2015, IATF 16949:2016 and responsible for their implementation.
- Certified Internal Auditor in ISO 14001:2015 and ISO 45001:2018 and responsible for their implementation.
- Medical Device Manufacturing in compliance with applicable foreign and domestic Regulations
- Regulations including US FDA 21 CFR Part 820, ISO 13485, EU Medical Device Regulation
- Handling of Customer Audits
- Management Review Meeting Data Preparation
- Sheet Metal, Assembly, Injection molding, Rubber Molding, Paint Shop, Plating & Powder Coating
- PFMEA, PPAP, APQP, MSA, SPC.
- Expertise in utilizing Quality & Excellence tools such as DMAIC, 7 QC, 8D, PDCA, VSM, ECRS and FCID etc.
- Ability to multitask and prioritize work.
- VAVE cost saving project.
Timeline
Sr. Engineer - SQA
Qure Medical Devices
06.2022 - Current
Engineer - SQA, QMS & Manufacturing excellence
Sanoh India Private Limited
10.2018 - 10.2022
Engineer - SQA/QA
Sadhu Forging
01.2017 - 09.2018
Engineer - QA/Customer Complaint
Genus Electrotech Limited
06.2014 - 09.2016
B.Tech. - Mechanical Engineering
West Bengal University of Technology
01.2010 - 01.2014
12th - undefined
Kendriya Vidyalaya
01.2008 - 01.2009
10th - undefined
Kendriya Vidyalaya
01.2006 - 01.2007