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Himanshu Patel
Rabda , Valsad
396055, Gujarat
9724214349 | [email protected] |
Objective
Highly skilled and results-driven Quality Assurance (QA) professional with over 8.5 years
of experience in the medical device and manufacturing industries. Expertise in process
optimization, compliance with regulatory standards, and cross-functional collaboration.
Currently contributing to SURU International Pvt. Ltd. while maintaining a strong track
record from previous work at Meril Endo Surgery Pvt. Ltd.. Seeking to leverage my
experience and technical proficiency to further enhance the QA processes in a challenging
role.
Professional Experience
SURU International Pvt. Ltd.
Manager Quality Assurance

Oct-2024 – Present
[Dahanu-Mumbai]
 Lead quality assurance activities for a range of products within the medical device
sector, ensuring compliance with international standards (ISO 9001:2015, ISO
13485:2016, EU MDR 2017 etc.).
 To handle Internal as well as External Audits. (USFDA, WHO, CE Certification,
etc..)
 Manage the preparation and submission of regulatory Documents for local and
international market
 To handle Supplier Audits and Supplier Qualification. Coordinating with various
external suppliers /service providers.
 To handle Deviations, Non-Conformance
 Collaborate with cross-functional teams to resolve customer complaints, root cause
investigations, and corrective/preventive actions (CAPA).
 Inspection of production operation periodically and check on the implementation of
Standard Operating Procedures (SOP) during the Production operation.
 Responsible for ensuring all calibration and validation activities are completed in
strict accordance with the annual calendar plan, maintaining compliance and optimal
equipment performance.
 Inspection for compliance with GMP/GDP practices.
 Experience in validation activities, Good understanding of engineering principles and
IQ, OQ, PQ documentation is an asset.
 Implement risk management strategies for products, working with the R&D and
production teams to ensure safety and compliance.
 Ensure smooth internal audits and external inspections, managing documentation and
ensuring adherence to regulatory requirements.
 Train and mentor junior QA persons on best practices for quality control and process
improvement.
Meril Endo Surgery Pvt. Ltd.
Quality Assurance Engineer

Jun-2016 – Oct-2024
[Vapi]
 Managed quality control and assurance processes for medical devices used in
endoscopic surgeries, ensuring compliance with GMP (Good Manufacturing
Practices), ISO 9001:2015, ISO 13485:2016, 21 CFR, ICH and CE Marking.
 To handle Deviations, Non-Conformance and Corrective and Preventive Actions
(CAPA Initiator, Coordinator and Investigator)
 Performing internal audits & Lead IQA
 Conducted in-process inspections, final product testing, and packaging audits to
ensure products met the highest standards of quality.
 Developed and maintained Standard Operating Procedures (SOPs) for all QA-related
processes.
 Complaint investigation / handling, root cause analysis, corrective action, and
preventive action.
 Experience in validation activities, Good understanding of engineering principles and
IQ, OQ, PQ documentation is an asset.
 Played a key role in internal and external audits, liaising with regulatory bodies (e.g.,
USFDA, CE, WHO,) to ensure all regulatory requirements were met.
 To handle final review, storage and approval of Product and Packaging Material
Artworks.
 Knowledge of Stability.
 BMR released in SAP System.
 Inspection of Raw material/ In-process/Finished product quality documents.
 Knowledge of Stability.
 To execute Line Clearance across all manufacturing & packing areas.
 Providing training to staff on quality assurance procedures and protocols to maintain
consistency in product quality.
 Led a team that achieved successful re-certification of ISO 13485:2016 without any
major findings.
 Played an instrumental role in reducing product rework by 25% by optimizing quality
control processes.
Projects & Achievements
 [Online Documentation]: Under the guidance of our Department Head, we’ve digitized
all key documents—SOPs, NC/CAPA, Stability reports, and Validation records—into the
Matrix software, ensuring seamless access, improved organization, and greater operational
efficiency
 [Implementation DOC form in SAP]: Previously, the Supply Chain team had to
coordinate with QA/RA to access the DOC form. However, with the implementation of DOC
in SAP, they can now seamlessly download the form from anywhere in the world, using the
company's secure SAP server.
Certifications
 ISO 13485:2016 Internal Auditor – [TUV SUD] (2022).

 MDSAP Training - [TUV SUD] (2023).
Education
Key Skills
 Quality Assurance & Control: Quality audits, inspections, validation & verification,
testing, and documentation.
 Regulatory Compliance: ISO 9001, ISO 13485, FDA, CE, GMP,21 CFR 820
 Root Cause Analysis: CAPA, 5 Whys, Fishbone diagram,
 Software Proficiency: Microsoft Office Suite, ZOHO, QMS software (e.g., Matrix).
 Communication: Strong interpersonal skills; proficient in preparing reports, training
materials, and delivering presentations.
Best Regards,
Himanshu Patel

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Himanshu Patel

SURU International Pvt. Ltd.

Manager Quality Assurance

Meril Endo Surgery Pvt. Ltd.

Quality Assurance Engineer

Projects & Achievements

 ISO 13485:2016 Internal Auditor – [TUV SUD] (2022).

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