RESUME

Malkit Rai

+917*********

adxivq@r.postjobfree.com

SUMMARY

Analytical, business-minded engineer with extensive experience in planning and improving manufacturing operations within fast-paced automotive, medical device, and precision engineering industries. Innovative strategist, skilled in developing and implementing continuous improvement initiatives aimed at cutting costs, bolstering productivity, and supporting the goal of operational excellence. Highly skilled quality assurance manager with a proven track record of implementing and maintaining ISO certifications like 9001, 14001, 18001, 13485, EU MDR, U.S. FDA and MDSAP etc.

WORK EXPERIENCE

Senior Manager QA

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 Ortho-paediatric medical devices throughout the globe. The facility is ISO 13485:2016, USFDA certified and TAA compliant and has world class manufacturing.

Key Responsibilities

Communication & Authority: Direction and oversight of QMS, organisational functions and processes to ensure compliance with ISO 13485:2016, ISO14971:2019, EU MDD/ MDR), MDSAP regulatory jurisdictions, and international regions where the organisation intends to market their products.

Oversee all external regulatory and compliance audits (NB/CB, Regulatory Bodies), including the facilitation (and/ or delegation) of critical supplier audits and evaluations.

Developing & Maintaining the QMS, EHS Policies and Procedures as per ISO 13485 and ISO 45001/OHSAS 18001 requirements and corporate guidelines including the customer defined requirements and country’s legal requirements.

Representation: 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.

Provide 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 Improvements Process (CIP), 5S, 8D, 3M, RCA, CAPA, EHS, HIRA etc.

Quality Management: Defining the financial objectives by preparing the quality assurance budget, scheduling expenditures, analysing variances, and initiating corrective actions.

Customer Complaints and Satisfaction: Ensuring timely resolution of customer complaints by submitting the CAPA and clarifying the concerns to keep the customer satisfaction a level up.

Good Manufacturing Practices: Advising and implementing the GMPs and Customer defined controls, responsible to comply with QC incoming, in-process, and final inspection for all the products on site.

Continued Education: Reviewing the VOC and spreading the awareness on the floor, defining the CTQs. Developed a team of Internal Auditors to ensure the compliance to standard throughout the organization.

Responsibility and Accountability: Responsible for Supplier Selection and Evaluation, Day to day Quality Activities to run the plant smoothly, Process Validation to ensure consistent quality products, conducting 5s Audit, Gemba walk to dig down the RCAs and action items in case of repeated defects.

Senior 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

Handling the responsibilities of implementing ISO 9001:2015, ISO 45001:2018 & ISO 14001:2015 in the organization.

Ensuring the robust system in place & its adherence to improve Quality and Safety.

Monitoring the Management Systems performance by reviewing departmental monthly KPIs and sharing action plan with top management.

Planning and adhering the Internal Quality audits, preparing reports, and raising Non-conformances, conducting MRM.

Ensuring day to day activities related to Quality in the plant including QC Manpower planning, Incoming Material Inspection, Releasing Finished Material, Managing test lab etc.

Implementing 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.

Responsible for handling customer complaints, warranty claims and submitting CAPA to customer within agreed timelines.

Leading process improvement projects and continuous improvement initiatives for reduction of process costs and rejections.

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.

Accountable for communication with agencies for external audits and inspections, including FDA, MDD, CMDCAS and readiness audit ISO13485.

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.

Accountable for supplier management including supplier selection, supplier assessment and re-assessment, as well as their education and further development.

Established and maintained the cross functional team’s communication to ensure efficiency in process operations.

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.

Prepared Annual Quality Plan, Management Programs, and operational control procedures (OCP's) for both EHS and QMS.

Senior Engineer QA

JREW Engineering Limited, Chandigarh Jan 2004 – Mar 2007

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, Claas Germany etc.

Key Responsibilities

To lead the development of receiving gauges /fixtures /tools for new developing parts & give inputs for concept design in fixtures/tooling/ process developments.

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,

Prepared Quality system documents for ISO 9000.

Coordinate documentation, MRM summary, internal audits, and corrective actions to ensure compliance of Quality Management System.

EDUCATION

William Carey University M Tech, Mechanical Engineering 2012

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

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 2013

Internal Auditor ISO 9001:2008, awareness program by TUV 2013

ACHIEVEMENTS

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 2013

Development of Receiving Gauge Reduction in inspection time by 60% by implementing receiving gauge for JCB front Axle 2006

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 140301, Contact – 078********

Malkit Rai

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