Sanjeev Kumar Sehgal Head of Department (QA)

adhdn6@r.postjobfree.com www.linkedin.com/in/sanjeev-sehgal-69181013/ 647-***-**** Stouffville, ON L4A 0P9

An action-oriented, manage, quality control and quality assurance with 18 years' success in progressive roles in Medical, Automotive and non-automotive sectors. Expertise applying ISO13485:2016, ISO19011:2018, ISO45001:2018, ISO9001: 2015 and IATF: 2016 standards. Adept at ensuring quality objectives are in alignment to customer requirements, statutory regulations, and corporate policy. Perceptive, influential leader with acute business acumen and expertise in building and leading high-performance teams. Expert negotiator and businessperson; able to forge solid relationships with partners and build consensus across multiple organizational levels.

Areas of Expertise include:

Quality Management

Team Building & Leadership

Supply Chain Management

Auditing

Operations Management

Supplier Management

Lean Manufacturing

Quality Auditing

Value Stream Mapping

Six Sigma proficiency

Root Cause Analysis

Quality Tools

Risk Management

Training & Development

Professional Experience

Eberspaecher-Vecture Inc. •Vaughan, ON • Jan 2019 to Present

Head of Quality Department 2019 to Present and Chair person of Health and Safety and report to President

Current Objective: Get the organization certified to ISO 9001:2015 (stage1 cleared)

Management Rep of QMS, Have strong skills in Time Management, analytical and Leadership

Implement and maintain quality management system and business processes in compliance with lean principles, ISO 13485 standard, FDA QS Reg (21 CFR part 820) and customer requirements.

Ensure product is built with compliance to legal, Regulatory & statutory standards and meets customer expectations and quality policy is followed

Ensure adherence to health and safety guidelines. Familiar with OHSA Regulations.

Plan and Schedule Risk based Internal Audit for internal and external processes (Manufacturing and business processes)

Encourage continuous improvement in the QMS processes. Ensure effective Quality Control processes

Manage the measurement and monitoring of QMS processes. Report Monthly KPI organization-wide to Top Management and relevant interested parties

Prepare, achieve and submit annual quality objectives to Top Management

Root Cause, Corrective Action, SCAPA, Six Sigma, Lean, IPC standards, REACH and RoHS Awareness, Good Documentation Practices

Ensure Supplier quality by reviewing SCAR, monitor supplier score cards, supplier QMS, supplier audit

Ensure Supplier related milestones are met along with Purchasing and Quality team.

Manage Corrective Action and Preventative Actions (CAPAs), Risk Register, Internal audits, complaints and feedback

Conduct Risk assessments

Draft IQOQPQ and PPQ for the medical devices customer

Participate in the management of external quality and regulatory audits and lead the resolution of any observations or deficiencies

Provide approval of deviations, non-conformances

Aim to ensure products and service fit for purpose and use

Set Objectives for the Quality Department, lead team meetings and encourage team cohesion.

Assist/Supervise Engineer, Specialist, quality supervisor, inspectors and other staff and provide guidance and feedback

Train, Motivate, coach and mentor employees to ensure that standards are met.

Manage QMS focused staff in selection, recruitment, learning & development

Identify needs and implement documented processes via procedures, documentation and system changes to meet customer requirements and achieve objectives

Monitor budget for Quality department throughout year

Key Accomplishments:

Lead efforts and achieved international standards for quality management, earning ISO13485:2016 with zero non-conformity

Have conducted Continuous Improvement projects using Kaizen and Six sigma approach based on processes, products and customer requirements

SPAN Manufacturing Inc. • Markham, ON • 2002 to Jan 2019

Quality Assurance Manager, 2013 - Jan 2019

Implement and maintain quality management system and business processes in compliance with lean principles, International Automotive Task Force (IATF) standards, and customer requirements. Plan and schedule internal and external audits based on process, customer feedback, and Registrar feedback. Manage recertification audits, ensuring organization meets Corporate Social Responsibility (CSR) and IATF standards. Liaise with clients throughout product development and launch to resolve quality and design issues. Monitor supplier risk and compliance, leading process improvements based on score cards and supplier performance audits. Train and mentor quality assurance personnel, including supervisor, inspectors, and coordinators. Use Process Failure Mode Effects Analysis (PFMEA) to evaluate risk and determine efficacy of corrective actions.

Key Accomplishments:

Lead efforts to achieve international standards for quality management, earning IATF 16949 and upgrading systems and processes to be compliant with IATF 16949 and ISO9001.

Maintain quality standards for deliverables, increasing First Time Quality (FTQ) by 20% and reducing rejection rate by 3% by implementing predictive maintenance process, saving approximately $2k monthly in labour costs.

Spearhead process improvements, identifying Non-value Added (NVA) processes, simplifying, combining, and eliminating redundant processes; increased efficiency by 10%.

Implement quality improvements, reducing Risk Priority Number (RPN) from 100 to 10 and improving customer satisfaction, maintaining First Pass Yield (FPY) of more than 95%.

Sr. Quality Assurance Engineer, 2002 to 2013

Planned, scheduled, and conducted internal and supplier quality audits, collecting objective evidence to ensure effective operation of Quality Management Systems (QMS). Evaluated and documented results for all implemented corrective actions using quality management tools. Supervised and trained internal auditors, ensuring workmanship was compliant with corporate and customer requirements. Fostered employee engagement through employee empowerment. Managed supplier capabilities, monitoring and evaluating supplier score cards, supplier meetings, and supplier certification. Created and reviewed KPIs to ensure quality objectives were met site-wide, defining action plans and driving improvements. Prepared and updated documentation, including work instructions, process flow documents, and policy manuals. Strong background in all SMT processes (SMT, reflow, wave soldering, and the related equipment, Thru-Hole technology and process development. Lead all quality related issues.

Key Accomplishments:

Led continuous process improvement projects based on Six Sigma process approach: Reduced Cycle Time, Increased Reliability, Process Automation.

Streamlined operations, reducing cycle time by changing panel layout; increased efficiency by 5%.

Developed and implemented quality improvements, introducing sensors on conveyor, modifying components not compatible to pad geometry, and reducing RPN by error- and mistake-proofing methods.

Automated process for data collection, regulating temperature and relative humidity and saving hidden labour costs.

Education

Bachelor of Engineering, Electronics & Communication Engineering,

Gulbarga University • India

Engineering equivalent evaluated by:

Comparative Education Service, University of Toronto, Toronto, ON

International Education Evaluations, Inc., North Carolina, USA

Canadian Council of Professional Engineers

Eligible for P.E.O.

Certificates & Licenses

Occupational Health & Safety Management System (OH&S MS) ISO 45001:2018 Program, BSi Management Systems,

Understanding, Documenting & Implementing IATF 16949 Program, OMNEX, 2017

Lead Auditor, IATF 16949, OMNEX, 2017

Internal Auditor IATF 16949, BSi Management Systems

Internal Auditor ISO 9001, BSi Management Systems

Six Sigma Green Belt, SimpliLearn, 2013

ISO/TS16949, Internal Auditor Program, Array

JHSC OHSA (Part I & II), Safety One

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