Quality Assurance Control
Resume:
RESUME
Malkit Rai
************@*****.***
SUMMARY
Experienced Mechanical Engineer with 17 years of expertise in Quality Assurance (QA), Quality Control (QC), and Operational Excellence. Adept at implementing and managing QMS documentation, internal audits, CAPA, and RCA to drive continuous improvements. Skilled in 5S, Kaizen, and Six Sigma methodologies, ensuring efficiency, compliance, and process optimization. Strong problem-solving abilities with a focus on process improvements, operational excellence, and team training. A proactive leader dedicated to enhancing quality standards and driving sustainable business growth.
WORK EXPERIENCE
Senior Manager Quality Assurance
United Surgical Limited, Bangladesh May 2021 – Present
Working as an Expatriate with a US MNC at Bangladesh, 100% EOU that manufacture and supply various types and sizes orthopaedic medical devices throughout the globe. The facility is ISO 13485:2016 certified and TAA compliant and has world class manufacturing.
Key Responsibilities
Strategy Development: Developing & Maintaining the QMS plan, Policies and Procedures as per ISO 13485, ISO 14001, ISO 45001, SA8000 (SMETA), requirements and corporate guidelines including the customer defined requirements as required.
Representation & Authority: Assigned as Management Representative for the organization and held accountable for all communication related to QMS with Certification Body, Customers, and local Authorities as required.
Leadership and Expertise: Developing Policies and procedures for all cross functional departments relevant to manufacturing. On all aspects of QMS including Gap assessment, Training, Problem Solving, Kaizen, Continuous Improvement Process (CIP), 5S, 8D, 3M, RCA, CAPA, EIA, HIRA, Product & Process Risk Assessment etc.
Team management: Directly managing a team of 13 engineers in Quality Assurance and Quality Control, including their selection, training on various aspects of new product development, product and process quality, QMS requirements, customer requirements etc.
KPI: Monitoring KPI for QA/QC team, defining and agreeing on action plans to achieve goals; promote and demonstrate effective communication and positive culture to meet the functional and organizational goals.
Standard development: Developed and implemented measurement standards throughout the organization including Lab test standards as per international norms and/or customer requirements, VMS, CMM, UTM, Microscope, Accelerated Reliability Tests (ARTs), Color Fastness, Tensile Strength (ASTM, ISO), Cytotoxicity (at 3rd party location).
Documentation Compliance: Preparing QA documents for DHR files for new product development like risk assessment and mitigation plan, Test plans and acceptance standards, measurement techniques etc.
Customer Complaints and Satisfaction: Ensuring timely resolution of customer complaints by submitting the CAPA and keeping the customer satisfaction level up.
Good Manufacturing Practices: Advising and implementing the GMPs, COPQ (Cost of Poor Quality) and Customer defined controls the initial stages of product development.
Continued Education: Reviewed the VOC and enhancing the awareness on the floor, defining the CTQs. Developed a team of Internal Auditors to ensure the compliance to standard throughout the organization.
Manager QA
KDDL Limited, Derabassi Sep 2018 – May 2021
A Precision engineering parts manufacturing company dealing in manufacturing and supply of high-end watch dials to various renowned brands in India as well as abroad like Titan, Timex, Fossil, Rado, Rolex, Tissot, CK, Victorinox, MBM, Grovana, TCM etc. KDDL has other subsidiaries dealing into different parts of watch as well as other precision engineering components.
Job Responsibilities & Duties
Implemented ISO 9001:2015, ISO 45001:2018 & ISO 14001:2015 in the organization.
Developed Inspection standards at each stage using Profile Projectors, Microscopes, Vision Measurement system (VMS) as appropriate and customer defined methods etc.
Managed the Management Systems performance by reviewing departmental monthly KPIs and sharing action plan with top management.
Planned and conducted the Internal Quality audits, preparing reports, and raising Non-conformances, conducting MRM.
Co-ordinated for day-to-day activities related to Quality in the plant including QC Manpower planning, Incoming Material Inspection, Releasing Finished Material, Managing test lab etc.
Held responsible regular skill development by regular training sessions on Problem solving/ 7QC tools, D8/CAPA, Health and safety, measurements and meteorology, Personal Safety, Environmental Safety, 5s etc.
Developed APQP, FMEA, Test standards, Acceptance levels during product development stages by co-ordinating Swiss customers.
Handled customer complaints, warranty claims and submitting CAPA to customer within agreed timelines.
Lead process improvement projects and continuous improvement initiatives for reduction of process costs and rejections.
Managed a team of 20 engineers and supervisors in QA and QC for enhanced product quality and lower rejection rates.
QA Manager & MR
Teleflex Medical, Chandigarh Dec 2012 - Aug 2018
An ISO certified (ISO9001, ISO 13485, ISO 14001, OHSAS 18001, cGMP & USFDA) company in the field of Medical devices. 100% export-oriented unit manufacturing medical devices for airway management system, emergency situations and operation theatre equipment.
Job Responsibilities & Duties
Prepared documentation for QMS/ ISO 9001, ISO 13485, ISO 14001, OHSAS 18001 including its implementation.
Delivered training on QMS, GMP, CAPA, 7QC tools, EHS, assembly processes, online testing, Measurement of uncertainty & Bias, 5s, 3M for different levels etc.
Supported software team to develop and test the software used in production planning and quality management system.
Handled a team of 8 engineers in quality, including 2 in new product development.
Accountable for supplier management including supplier selection, supplier assessment and re-assessment, as well as their education and further development.
Established and maintained critical process’s control (e.g. ETO, Induction welding, Ultrasonic Welding) to ensure high degree of compliance to standards and desired quality.
Developed equipment validation including IQ, OQ and PQ, qualification reports, first article reports, manufacturing work instructions.
Implemented the company's environmental, health, and safety policies effectively. Managed internal Quality audit and conducted management reviews.
Involved & assisted different department in preparation Risk Assessment, Carry out self-evaluation as per Global EHS Road map-standards.
Applied Six Sigma tools including the manufacturing FMEA, DOE, SPC, MSA, APQP, 8D etc.
Took care of measuring equipment calibrations, gauge validation, and correctness of CMM, Height Master, VMS.
Senior Engineer QA
JREW Engineering Limited, Chandigarh Oct 2010 – Dec 2012
JEL is a leading organization for heavy duty fabrication of automotive parts, agricultural equipment, earth moving machinery components, harvesting combine parts, material handling equipment etc. ISO9000, certified company. It is one of the OEM suppliers of JCB, Tarex, ECEL, ACE, Claas India etc.
Key Responsibilities
Handled New Supplier assessments, supplier evaluation process including quality & compliance audits.
Monitored defects and provided feedback to suppliers to identify any existing problems by use of 7QC tools, problem solving tools & eliminate root cause sustainably on appropriate system,
Programming in Co-ordinate measuring machine (CMM), Profile Projector, UTM tests and inspecting the finished goods prior moving to finished goods warehouse.
Prepared documentation ISO 9000, FMEA, CAPA, RCA, PSW etc, internal audits, and corrective actions to ensure compliance of Quality Management System.
Supplier Quality
Eastman Impex, Ludhiana Jan 2004 – Mar 2007
EI is an export house for Construction equipment, Hand tools, Garden tools, Automotive components, fabrication items.
Key Responsibilities
Handled Production schedule compliance at designated suppliers.
Ensuring compliance with given specifications.
Ensuring required quality specs are being met prior to releasing material for shipment.
Taking CAPA for identified RCA against customer complaints.
EDUCATION
William Carey University B Tech, Mechanical Engineering 2010
Punjab state Board of Technical
Education & Industrial Training Diploma Mechanical Engineering 2002
PSEB Senior Secondary schooling 2001
PSEB Higher Secondary Schooling 1999
CONTINUING EDUCATION
Lead Auditor ISO 13485:2016 TUV SUD South Asia 2024
AATCC & ASTM Test Method Training SGS and AATCC 2021
ZED Consultant Confederation of Indian Industries (CII) 2017
Internal Auditor ISO 50001, Energy Management System 2017
Internal Auditor ISO 13485:2016, BSi 2016
Six Sigma Green Belt Cert Business and Scientific Experiment 2015
Lead Auditor OHSAS 18001:2007, BSi 2015
Lead Auditor ISO 13485:2012, BSi 2014
Internal Auditor ISO 9001:2008, awareness program by TUV 2013
ACHIEVEMENTS
Achieved 3rd Surveillance
Without any non-conformance ISO 13485:2016, ISO 14001:2018 2024
Productivity enhancement Enhanced capacity through VSM, by 16% to ship 11.5M units 2022
Rework Reduction Reduced rework rate from 8.20% to 3% by implementing TQM 2022
Recyclable Packaging Developed recyclable packaging for the Swiss Customers
resulting in a saving of INR 2M per year 2020
IMS Up-gradation Successfully up graded the IMS (ISO 9001, ISO 14001) with zero
observations from certification body. 2017
Rejection Cost Savings Delivered (2) cost savings projects totalling INR1800K 2015
Implementation of ISO 13485 Implemented ISO 13485:2003 with
Zero Observation form notified body 2014
Development of Receiving Gauge Reduction in inspection time by 60% by implementing receiving gauge for JCB front Axle 2011
SOFT SKILLS
Software Proficiencies ERP/SAP, Outlook, PowerPoint, MS Project, MSWord, Visio,
MS Access & Excel etc.
PERSONAL INFORMATION
Date of Birth 20th Nov 1983
Marital status Married
Permanent Address House No. 22, Preet Enclave, Near Anaj Mandi, Sector 10
Kharar, Punjab – 140301, Contact – +917*********, +880**********
Malkit Rai
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