Arunkumar B
Periyar Street, Redhills, Chennai
Summary
Dynamic Engineer with an overall experience of 8+ years, which includes 5+ years of experience in medical devices, post-market quality, complaint handling processes, and working knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, ISO 13485, ISO 14971, and European Medical Device Regulations. Seeking to leverage my skills in ensuring regulatory compliance and facilitating efficient product approvals.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Post Market Surveillance Lead
HCL Technologies LTD
Chennai
05.2021 - Current
- Managing and monitoring of the complaint handling process.
- Performed end-to-end complaints handling: intake, executed DTs reportability decisions, analyzed investigation activities info. Of device failures, MDR processing, and electronically submitting to the FDA.
- Perform a complaint investigation in a timely manner to determine the root cause, and recommend appropriate CAPAs.
- Expertise in the submission of eMDRs and SeMDRs, interacting with all stakeholders to clarify the scope of work.
- Familiarity with FDA 21 CFR parts 820, 803, 806, and EUMDR.
- Certified Internal Auditor for ISO 13485:2016 (MQMS), ISO 9001:2015 (QMS), ISO 14001:2015 (EMS), ISO 45001:2018 (OH&SMS), and IATF 16949:2016 (QMS).
- Ensuring compliance with FDA Quality System Regulations, EU MDR, ISO 13485, ISO 14971, IEC 60601, and other relevant industry standards during product development and changes.
- Prepares for and assists with leading product performance trend meetings (weekly FACTS meetings).
- Review vigilance and other databases for relevant complaint information in support of the risk management activities.
- Provide internal guidance and education regarding customer complaint processing, MDRs, and regulatory compliance.
- Utilization of database systems used to process complaints, and to create and measure quality metrics.
- Reviewing Design History Files and Technical Files to ensure alignment with applicable requirements.
- Experienced in handling Life Cycle Management of the Medical Device.
- Familiar with statistical software tools, such as Minitab.
- Familiar with DMAIC methodologies.
- Execute audits according to the plan, prepare the audit reports, and maintain all audit records.
- Follow up on internal and external CAPA to ensure timely implementation and validate their effectiveness.
- Experienced in Project Management, and Handling communication with cross-functional teams.
- Responsible for continuous improvements in the process.
Sr. Engineer - Quality
Omega Bright
Chennai
10.2020 - Current
- Responsible for the analysis of customer complaints, visiting customer ends to solve issues, and preparing reports.
- Execute audits according to the plan, prepare the audit reports, and maintain all audit records.
- Knowledge and experience in core tools (PFMEA, MSA, SPC, APQP, PPAP). Experienced in working with SAP and MS Office.
- Experienced in working with SAP and MS Office.
- Follow up on internal and external CAPA to ensure timely implementation and validate their effectiveness.
- Conducting the Management Review Meeting as per the frequency timeline.
- Ensure the update and tracking of calibration records for all quality equipment.
- Quality check of the end product by mechanical testing methods.
Quality Engineer
Arkkays National Engineering and fdry Co.
09.2017 - 10.2020
- Execute audits according to the plan, prepare the audit reports, and maintain all audit records.
- Knowledge and experience in core tools (PFMEA, MSA, SPC, APQP, PPAP). Experienced in working with SAP and MS Office.
- Experienced in working with SAP and MS Office.
- Follow up on internal and external CAPA to ensure timely implementation and validate their effectiveness.
- Conducting the Management Review Meeting as per the frequency timeline.
- Ensure the update and tracking of calibration records for all quality equipment.
- Quality check of the end product by mechanical testing methods.
Site Supporting Engineer
(Accurate logistics) Third Party
03.2017 - 08.2017
- Key responsibilities:
·Site Quality Inspection of Pipes and MS Pipes.
·Quality check of Raw materials & End Product.
·Customer Handling(TWAD)
Trainee- Line Inspector
Sri Mukha Precision Products- Unit VI
08.2016 - 02.2017
- Process planning and product development based on customer requirements.
- Directly supervising hourly production, maintaining, and updating the quality documents like FOA, IR, GFA, SR, IIR, and FIR.
- Procurement and maintenance of tools and gauges for production.
- Quality check of raw materials and end product.
- Knowledge and implementation of 5S, KAIZEN.
Education
BE - Mechanical Engineering -
Rajalakshmi Institute of Technology
Chennai04-2016
HSC - Computer Science -
St. Marys MHSS
01.2012
SSC -
St. Marys MHSS
01.2010
Skills
- EU MDR
- US FDA
- IEC 62304, 82304, 62366
- Software guidance for 510(k) submission
- SaMD
- IMDRF Coding
- ISO 13485, 14971, 9001
- CAPA
- Quality Assurance
- Internal and Supplier Auditor
- PMS
Softwares Handled
- Trackwise
- Salesforce
- SAP
- MS office
- Power BI
- Minitab
- PMSmart
Certification
- Internal Auditor - ISO 13485
- Internal Auditor - ISO 9001
- Internal Auditor - ISO 14001&45001
- Internal Auditor - IATF 16949
- Six Sigma
- Project Management
Accomplishments
Successful completion of External Surveillance Audit.
Revamped QMS in the entire organization as a team as per
ISO 13485.
Timeline
Post Market Surveillance Lead
HCL Technologies LTD
05.2021 - Current
Sr. Engineer - Quality
Omega Bright
10.2020 - Current
Quality Engineer
Arkkays National Engineering and fdry Co.
09.2017 - 10.2020
Site Supporting Engineer
(Accurate logistics) Third Party
03.2017 - 08.2017
Trainee- Line Inspector
Sri Mukha Precision Products- Unit VI
08.2016 - 02.2017
BE - Mechanical Engineering -
Rajalakshmi Institute of Technology
HSC - Computer Science -
St. Marys MHSS
SSC -
St. Marys MHSS
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