Kalyani Nikam
Pune
Summary
Accomplished professional with extensive experience of approximately 9 years in medical device gap assessment of technical files, and the creation of technical documentation in compliance with US FDA and EU MDD 93/42/EEC, and MDR 747/2017. TUV-Certified Internal Auditor for ISO 13485:2016, with a proven track record in the implementation of Quality Management Systems per ISO 13485:2016. Possesses a strong working knowledge of design controls, risk management, and requirements management. Skilled in creating technical files for Class I, II, and III medical devices, including orthopedic implants and instruments.
Core competencies include ISO 13485, Risk Management, ISO 14971, Design Control, Gap Assessment, EU MDR Technical File Creation, and FDA 21 CFR 820. Recognized for strong critical thinking and problem-solving abilities, coupled with a successful several-year track record in the industry.
Overview
9
9
years of professional experience
1
1
Certification
Work History
CAPA-Quality Engineer
Philips India Ltd.
05.2024 - Current
- Led product and process CAPA investigations from issue identification to solution implementation and effectiveness monitoring, driving continuous improvement.
- Managed CAPA projects by coordinating cross-functional teams, scheduling meetings, and ensuring deliverables meet timelines.
- Represented CAPAs during audits and review boards.
- Guided teams in root cause analysis techniques like Pride problem solving to resolve complex issues effectively.
- Executed detailed CAPA tasks, including issue assessment and root cause analysis, ensuring thorough investigation and resolution.
- Directed complex CAPA engineering activities, assessed corrective actions, and led advanced quality problem solving.
- Acted as R&D representative in CAPA review boards, overseeing phase transitions and defining CAPA ownership.
- Built strong cross-disciplinary relationships to secure resources for R&D CAPA projects and establish initial ownership.
- Collaborated with R&D management for CAPA status reporting and ensured expert support from R&D clusters.
- Improved CAPA processes and templates in partnership with the QA CAPA manager, enhancing efficiency and quality.
- Managed audit support for CAPAs, ensuring readiness and compliance for quality and regulatory audits.
- Advocated quality-first culture by sharing impactful customer/patient stories, emphasizing the importance of quality.
Q&R Administrator
Philips India Ltd.
11.2021 - 05.2024
- As a training administrator, define a lean training and administration practice in scope.
- Ensure Training management system complies to intended use and regulatory requirement.
- Approve training prior to its usage and creation in TEDs tool.
- Ensure that training content is controlled and accessible to make changes.
- Ensure that Manager assigns trainings to their respective team members based on roles and responsibility.
- Report on Business Training KPIs to QMS managers.
- Support Managers by providing correct reports from tool and other necessary information.
- Give feedback to QMS Managers regarding noncompliance in trainings or training process.
- Support CAPA Owner in CAPA actions related to Training.
- Guide business leaders, program managers and people managers to understand major changes in organization with respect to trainings.
- Guide users to resolve technical issue that they may come across while performing any trainings.
- Participate in Internal and external audits by providing evidence of training process and activities to resolve auditor queries.
Regulatory Consultant
Capgemini India Ltd.
06.2021 - 10.2021
- Gap Assessment of Technical files.
- Creation and conducting in-house training session for EU MDR 2017/745 as follow:
- ANNEX 1- General Safety and performance requirements
- ANNEX 2- Technical Documentation
- ANNEX 8: Classification Rules of medical devices
- Conducting daily status meetings, weekly and monthly connect with management.
Technical Lead EU MDR Compliance (Onsite Germany – 9 Months)
Tata Elxsi Ltd.
Pune
10.2018 - 06.2021
- Lead teams and participate in daily project status meetings to communicate and resolve technical queries with client.
- Identify applicable MDR requirements for Class I, IIa and IIb surgical implants and instruments which are used in Knee, Hip and Spinal Implantation surgery.
- Conduct gap assessment of available technical documentation and identify gaps w.r.t MDR requirements and determine remediation strategy.
- Interact with client to discuss remediation strategy and to understand specific requirements if any.
- Created Technical Documents (GAP Assessment, standards checklist, CDS Form, Product Risk Analysis, GSPR checklist, V&V Rationale) to comply with EU-MDR 745/2017.
- Developed and implemented the SOP’s, review process and workflow for teams for standardization.
- Assessed Biological safety and created the Biological Evaluation Report per ISO 10993-1.
Process Engineer (US & EU Countries)
IZiel Healthcare
Pune
06.2016 - 10.2018
- Create/ Remediate Quality Management System procedures in compliance with FDA 21 CFR 820 and ISO 13485:2016 for clients.
- Create Design History File (DHF) documents as specified in the QMS procedures.
- Executed and documented process validation activities including Standard Operating Procedures (SOP’s), Validation Master Plan (MVP), IQs, OQs, PQs and Validation summary report (VSR).
- Client Appreciation for on Time delivery of Class I products per MDR compliance.
- Project Excellence Award for EU MDR Compliance Program Phase II.
- Received recognition in current role in Philips for performing Philips Behaviors.
Education
Bachelor of Engineering - Polymer Engineering
Pune University
Pune, India05.2015
Skills
- TUV Certified Internal Auditor
- Medical Device files Gap Assessment
- Technical Documentation
- USFDA Compliance
- EU MDD 93/42/EEC Compliance
- MDR 747/2017 Compliance
- ISO 13485:2016
- Quality Management System Implementation
- Design Controls
- Risk Management
- Requirements Management
- Technical File Creation
- ISO 14971
- EU MDR Technical File Creation
- FDA 21 CFR 820
- Management Updates
- Team coordination
- Root cause analysis
- Critical thinking
- Corrective action Preventive action
- Training administration
- Cross-functional teamwork
- Risk assessment
- Problem-solving abilities
Certification
- Certified Cognition Cockpit: Basic and Advanced User
- TUV SUD South Asia Certified Internal Auditor for ISO 13485: 2016
Accomplishments
- Client Appreciation for on Time delivery of Class I products per MDR compliance.
- Project Excellence Award for EU MDR Compliance Program, Phase II
- Received recognition in my current role at Philips for performing Philips behaviors
- Received the India Impact Award for making an impact on customers and patients by providing faster and quicker solutions to CAPAs
Languages
English, Fluent
Hobbies and Interests
- ISO 13485
- Audits
- Risk Management
- Technical File/ DHF Remediation
- MDSAP
Personal Information
- Date of Birth: 01/06/94
- Gender: Female
- Nationality: Indian
Job Skills
- Accomplished professional in Medical Device Gap Assessment of technical files, creation of technical documentation in compliance with USFDA and EU MDD 93/42/EEC & MDR 747/2017
- TUV Certified Internal Auditor for ISO 13485:2016
- Experienced in implementation of Quality Management System per ISO 13485:2016
- Working knowledge of Design Controls, Risk Management and Requirements management
- Experienced in creating Technical File for Class I, II, III Medical Devices such as Orthopedic Implants and Instruments
- Core Competencies: ISO 13485 & Risk Management ISO 14971, Design Control, Gap Assessment, EU MDR Technical File Creation, FDA 21 CFR 820
Affiliations
- I actively participate in workshops, seminars, and online courses to stay updated with the latest industry trends and advancements This commitment to learning ensures that I remain proficient in my field and can offer innovative solutions
- I attend industry conferences and networking events to connect with peers and experts Building a strong professional network helps me stay informed about new opportunities and best practices
Languages
Marathi
First Language
English
Proficient (C2)
C2
Hindi
Proficient (C2)
C2
German
Beginner (A1)
A1
Timeline
CAPA-Quality Engineer
Philips India Ltd.
05.2024 - Current
Q&R Administrator
Philips India Ltd.
11.2021 - 05.2024
Regulatory Consultant
Capgemini India Ltd.
06.2021 - 10.2021
Technical Lead EU MDR Compliance (Onsite Germany – 9 Months)
Tata Elxsi Ltd.
10.2018 - 06.2021
Process Engineer (US & EU Countries)
IZiel Healthcare
06.2016 - 10.2018
Bachelor of Engineering - Polymer Engineering
Pune University
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