Medical Device Quality & ISO Compliance Specialist

NAME: SUNDRAM KUMAR JHA

Mobile No.: +91-805*******

Email ID: ***.*******@*****.***

LinkedIn: https://www.linkedin.com/in/sundram-kumar-jha- 068091207

Languages: English (Fluent), Hindi (Native)

Mobility: Open to relocation Immediate availability Available for virtual interviews

• Quality Management System (QMS) Professional Medical Device Quality ISO-13485 & ISO-9001 Compliance Regulatory Documentation CAPA Internal Audits Management

Process Improvement Quality Compliance.

PROFESSIONAL SUMMARY

Results-driven Quality Management Systems (QMS) Professional with 5+ years of progressive experience in pharmaceutical manufacturing, medical devices and quality consultancy. Experienced in Quality Management System implementation, internal audits, ISO 13485 compliance, regulatory documentation, GMP, Good Documentation Practices (GDP), CAPA, document control and quality improvement initiatives. Strong expertise in microbiological quality control, Ethylene Oxide (ETO) sterilization, cleanroom validation, technical documentation and cross-functional team coordination. Currently supporting multiple medical device and pharmaceutical organizations in strengthening Quality Management Systems, improving regulatory compliance and preparing for certification audits. MBA in Healthcare & Operational Management with a strong commitment to operational excellence and continuous quality improvement. EDUCATIONAL QUALIFICATION

Examination Branch / Specialization University / Institute GPA / Details Year MBA

Healthcare & Operational

Management

Manav Rachna International

Institute of Research &

Studies, Faridabad

Focus: Operational

Management, Supply Chain

Management and Healthcare

CGPA: 8.33

2024-2026

M.Sc Biochemistry

Central University of

Haryana, Mahendergarh

Regular course; GPA:

7.28/10

2020-2022

B.Voc

Bio-medical Science

Central University of

Haryana, Mahendergarh

GPA: 6.99/10; Quality

Control, QA and Machine

Operation focus

2017-2020

PROFESSIONAL EXPERIENCE

QMS Manager - Consultant

Adwith. June 2026 – Present

• Support pharmaceutical, medical device and packaging organizations in implementing and maintaining Quality Management Systems

(QMS).

• Conduct internal audits to evaluate compliance with ISO 13485, GMP and Good Documentation Practices (GDP).

• Prepare comprehensive Audit Plans, Stage 1 Audit Reports, Stage 2 Audit Reports and Surveillance Audit Reports for certification readiness.

• Develop, review and standardize Quality Manuals, SOPs, HR Policies, quality procedures and controlled documentation.

• Develop GMP, GDP and quality documentation in accordance with applicable regulatory requirements.

• Prepare Minutes of Meeting (MoM), monitor project milestones and track action items for greenfield manufacturing facilities.

• Develop quality formats, templates and documentation systems to improve process standardization.

• Coordinate with client management through professional communication, documentation review and compliance follow-up.

• Support organizations in achieving audit readiness through documentation improvement and Quality Management System implementation.

• Assist clients in strengthening quality compliance through continuous process improvement initiatives. Assistant Manager - QC Microbiology

Hospi line Equipment Pvt. Ltd. Jan 2025 – May 2026

• Prepared and maintained Device Master Documentation and Batch Manufacturing Records (BMR) for medical devices.

• Operated and monitored Ethylene Oxide (ETO) sterilization processes for finished medical devices.

• Managed and supervised a team of approximately 50 production personnel to ensure smooth manufacturing operations.

• Coordinated finished goods dispatch activities while ensuring product quality and documentation compliance.

• Reviewed and verified finished product labels and packaging stickers prior to product release.

• Coordinated cleanroom qualification and validation activities with third-party agencies while monitoring execution and compliance.

• Performed sterility testing, bioburden testing and environmental monitoring to ensure microbiological quality compliance.

• Maintained GMP documentation and supported quality system compliance activities.

• Coordinated with QA, Production and Regulatory teams to ensure product quality and audit readiness. Analytical QC Chemist cum Microbiologist

Sterimed Surgical India Pvt. Ltd. Sep 2022 - Dec 2024

• Performed sterility testing, bacterial endotoxin testing (BET), bioburden testing and microbiological quality analysis of medical devices.

• Conducted physicochemical testing of raw materials, in-process samples and finished products.

• Operated depyrogenation ovens and supported sterilization activities for medical device components.

• Supported CAPA implementation, root cause investigations and quality improvement initiatives.

• Maintained vendor qualification and vendor agreement documentation.

• Performed environmental monitoring, media preparation and microbiological laboratory activities.

• Maintained GMP documentation, laboratory records and controlled documents in accordance with quality requirements.

• Coordinated with Quality Assurance and Production departments to ensure regulatory compliance and product quality. Apprentice Trainee - Microbiology / QC Support

Gentech Healthcare Pvt. Ltd. Jun 2021 - Sep 2022

• Performed raw material sampling and in-process sampling in accordance with approved quality procedures.

• Conducted quality control testing of raw materials and finished pharmaceutical products.

• Performed water quality testing and prepared analytical reports.

• Conducted dissolution testing, disintegration testing and UV spectrophotometric analysis.

• Performed daily verification of analytical balances and pH meters.

• Operated laboratory autoclaves and hot air ovens for routine laboratory activities.

• Maintained laboratory documentation and ensured compliance with Good Manufacturing Practices (GMP). TECHNICAL EXPERTISE

Quality Management Systems:- ISO 13485 • Internal Audits • CAPA • NCR • Root Cause Analysis • Change Control • Document Control

• SOP Development • Quality Manual • GMP • GDP • Audit Planning • Audit Reporting Regulatory & Documentation:- Quality Documentation • Controlled Documents • Batch Manufacturing Records (BMR) • Device Documentation • HR Policies • MoM • Audit Reports • Documentation Review Microbiology:- Sterility Testing • BET (LAL) • Bioburden Testing • Environmental Monitoring • Water Testing • Media Preparation • Cleanroom Monitoring • Aseptic Techniques

Equipment:- ETO Sterilizer • Autoclave • Laminar Air Flow • Incubator • Colony Counter • pH Meter • UV Spectrophotometer • Dissolution Apparatus • Disintegration Apparatus • Depyrogenation Oven CERTIFICATIONS

• ISO/IEC 17025:2017 - Laboratory Management Systems (CPD Certified) - Alison

• Drug Regulatory Affairs: FDA, EMA, eCTD & Global Compliance - Udemy

• How AI is Transforming Pharma: From R&D to Care Delivery - LinkedIn Learning

• Operations Management Foundations - LinkedIn Learning

• Building Trust & Global Collaboration Skills - LinkedIn Learning

• X-Culture Global Collaboration Certificate - 2024 ACHIEVEMENTS

• Supported multiple client organizations in achieving audit readiness through effective QMS implementation and documentation.

• Contributed to CAPA implementation and continuous quality improvement initiatives.

• Strengthened GMP compliance through standardized documentation and process improvement.

• Enhanced microbiological quality assurance and regulatory compliance across manufacturing operations.

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