Sanjay Muralidharan
Bangalore
Summary
Accomplished Design Quality Engineer having 7+ years experience with expertise in Design controls, CAPA and risk management, Post Market Surveillance ensuring compliance with ISO 13485. Strong analytical skills complemented by effective stakeholder management, driving quality improvements and enhancing product safety standards.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Design Quality Engineer
Philips Healthcare
Bengaluru
03.2024 - Current
- Strong quality assurance management experience
- Strong design control and complaints handling project experience
- Professional knowledge in product safety standards (e.g IEC 60601, IEC 62366 Usability, etc)
- Key member on CAPA decision making process, ensuring effectiveness of CAPA.
- Experience on CAPA Lifecycle from Initiation to implementation till closure.
- Post Market data analysis and create projects to fix the potential issues.
- Post market surveillance complaints analysis whichever impacts critical to Safety and Critical to Quality requirements.
- Ensure product-development processes and documentation meet Quality System requirements in relevant regulations, e.g 21 CFR 820.30 and ISO 13485.
- Strong statistical and analytical abilities (e.g Design for six sigma, design for reliability)
- Quality representative for of product defect management board, engineering change board
- Consolidating complaints data and providing suggestions to the leadership for initiating improvement projects
- Key member to ensure design transfer to production and collaborating with manufacturing team
- Participates in the decision-making process of product-quality related decisions
- Reviewed and approved quality-related documents, ensuring compliance with internal and external standards.
Quality Engineer
Becton Dickinson, BD
Bangalore
02.2022 - 03.2024
- Lead, prepared and participated as main escort in internal and external audits (e.gFDA, TUV, MDSAP, etc)
- Ensuring the product quality at the sites, working with onsite engineering and production team.
- Facilitated CAPA when gaps identified during Audits, potential complaints in the field.
- Design control activities, DHF Remediation
- Experience on Statistical Analysis (Minitab)
- Perform Process validation activities such as IQ, OQ and PQ
- Quality assessments will be done for every project to align with existing local procedures and global standards
- Key player for risk management activities for product development
- Reviewing Verification and Validation plan and report
- Monitoring Post Market Surveillance data for the products to identify new potential risks.
- Performing the investigation and creating CAPA if necessary
- Effective management of stakeholders and cross functional teams to achieve the target on time
- Handled Design control activities as per 21 CFR 820.30
- Reviewing test methods, DV plans, protocols and reports, Statistics (sampling plans)
Associate Consultant
Capgemini Technology Services
Pune
06.2021 - 02.2022
- Developed and tested prototypes of mechanical components utilizing CAD software.
- Participated in cross-functional team meetings to discuss project progress and timelines.
- Performed testing to determine functionality.
- Involved in Verification activities including creation of Test Method protocol and reports
- Handled Sustenance Engineering Projects
- Analyzed product designs for manufacturability, cost optimization and performance requirements.
- Created accurate project specifications, documenting in technical manuals.
Lead Engineer
HCL Technologies Ltd
Madurai
12.2017 - 06.2021
- Prepared estimates and budgets.
- Developed and tested prototypes of mechanical components utilizing CAD software.
- Hands-on experience with SolidWorks and CREO.
- Completed projects in compliance with Design control as per 21 CFR 820.30
- Analyzed design or requirement information for equipment or systems.
- Generated technical drawings, assembly instructions and bill of materials.
- Performed MDR labeling gap assessment.
- ECN/ECO creation for sustenance projects.
- Performed DHF remediation activities.
- Strong knowledge of medical device standards, ISO 13485, and ISO 14971.
Education
B.E - Mechanical Engineering
Anna University Affiliated
Skills
- Design Quality Assurance
- Design Verification & Validation
- Process Validation (IQ, OQ and PQ)
- CAPA & FMEAs
- Risk Management Activities (Risk Assessment)
- Supplier Management Activities
- Post Market Surveillance Analysis
- Design control
- Root cause analysis
- Non-Conformance Risk Assessment
- Design Control Activities
- PLM Activities (ECN/ECO)
- Statistical Analysis (Minitab)
Accomplishments
- Living the BD Way Award winner for exceptional performance at BD
- I received the Outstanding Performer Award twice for consistent performance at HCL
Certification
- American Society for Quality (ASQ) Certified Quality Engineer
https://credentials.asq.org/46b0048f-55eb-4b99-a585-689144fd3f51#gs.4l9k7n
Timeline
Design Quality Engineer
Philips Healthcare
03.2024 - Current
Quality Engineer
Becton Dickinson, BD
02.2022 - 03.2024
Associate Consultant
Capgemini Technology Services
06.2021 - 02.2022
Lead Engineer
HCL Technologies Ltd
12.2017 - 06.2021
B.E - Mechanical Engineering
Anna University Affiliated
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