Minakshi Buragohain
@minakshiburagohain
Project Manager with 10+ years driving ISO/FDA-compliant program delivery and Agile transformation.
IndiaWhat I'm looking for
I’m a Project Manager with over 10 years of experience across complex engineering and consultancy programs, owning end-to-end delivery—scope, cost, timeline, risk, and compliance—for 12+ global product lines. I bring a strong regulatory foundation with 100% compliance to ISO, FDA, and EU-MDR regulations and standards, building up to $1.1B in revenue through disciplined execution and governance.
In my roles at TCS, Amgen, and Olympus, I’ve led multiple platform releases, improved delivery costs by ~15%, and increased delivery predictability and stakeholder visibility by 30% through structured roadmaps, risk-based planning, and efficient follow-up processes. I also facilitate Agile transformations using Jira and Confluence—improving sprint velocity by 25% and boosting stakeholder engagement scores by 30%—while strengthening onboarding and training for remote teams to improve new hire productivity by 40% within the first three months. I’m known for aligning cross-functional teams across quality, risk, engineering, and supplier workstreams, ensuring design controls, V&V documentation, CAPA, and complaint management stay audit-ready.
Experience
Work history, roles, and key accomplishments
Led global advisory and delivery for 12+ medical device product lines, owning timelines, resourcing, risk, and regulatory compliance strategy with 100% ISO/FDA/EU-MDR adherence. Improved approval timelines by 15% and increased delivery predictability by 30% through Agile execution, governance, and enhanced stakeholder visibility.
Managed end-to-end risk management documentation for 6 product platforms in CDOCS, achieving 100% compliance accuracy with 21 CFR Part 820 and ISO 13485/ISO 14971. Reduced CAPA backlog by 15%, improved closure efficiency by 20%, and accelerated document approval turnaround by 50%.
Project Manager, Post-Market Quality
Olympus
Mar 2018 - Jan 2019 (10 months)
Led complaint management and medical event evaluation for 1,500+ cases using structured risk-based triage aligned with regulatory expectations. Improved CAPA initiation speed and accuracy and increased investigation turnaround/closure accuracy by 30% through enhanced documentation and supplier follow-ups.
Project Lead (Design Controls)
DePuy Mitek
May 2016 - Feb 2018 (1 year 9 months)
Oversaw risk assessments and gap analyses across 3 product families, reducing production non-conformities by 15%. Ensured DHF completeness and traceability and enabled release of 5 product variants with zero deviations through process compliance validation.
Design Engineer (Quality Systems)
DePuy TruMatch / Spine / Orthopaedics
May 2014 - May 2016 (2 years)
Supported change control, labeling, and IFU updates for 750+ documents while maintaining 100% regulatory compliance. Reduced rework cycles by 15–30% by partnering with manufacturing and suppliers to resolve documentation/design issues and maintained PLM/QMS data integrity with zero CAPA observations.
Education
Degrees, certifications, and relevant coursework
Sikkim Manipal Institute of Technology
Bachelor of Technology, Mechanical Engineering
2009 - 2013
B.Tech. in Mechanical Engineering from Sikkim Manipal Institute of Technology between 2009 and 2013.
Availability
Location
IndiaAuthorized to work in
Social media
Job categories
Skills
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