Cricket - Captain of 3 DIV FREM Cricket club, Valby, Denmark
Shamal Surain Kurukuladithya
Quality Management Research & Development Engineer
Kongens Lyngby
Summary
Quality Assurance Engineer with experience in R&D within the medical device industry at Ambu A/S, specializing in risk management, design control, and lifecycle quality engineering. Strong analytical and structured mindset, with a proven ability to translate regulatory and quality requirements into practical, defensible QA decisions. Recognized for providing clear quality guidance and supporting development teams in complex projects through risk-based decision-making, compliance alignment, and cross-functional collaboration. Experienced in managing nonconformities, CAPAs, and design changes while ensuring consistency, traceability, and audit readiness across the product lifecycle. Motivated by solving complex, high-impact quality challenges and contributing to robust, sustainable, and compliant product development.
Overview
2
2
Languages
6
6
Certifications
10
10
years of professional experience
Work History
Quality Management Research & Development Engineer
Ambu A/S
09.2021 - Current
Responsible for QA support across new development projects, lifecycle management, and post-market activities, ensuring compliance with regulatory and internal requirements.
Key contributions:
- Owned and supported risk management activities across development projects (RMP,PRE, RMR, benefit-risk)
- Provided QA support to design control, verification & validation activities
- Led and supported DCR, NCR, and CAPA processes, ensuring alignment with risk and regulatory expectations
- Supported post-market surveillance, complaint investigation, and quality reporting
- Contributed to process validation and manufacturing-related quality activities
- Actively participated in internal and external audits
- Supported QMS updates and alignment with regulatory standards
Product & Application Specialist – Medical and Surgical Devices
A. Baur & Company (Pvt.) Ltd.
01.2018 - 01.2019
Specialist for Hill-Rom, Trumpf Medical and HT Group agencies/brands in Surgical & Diagnostic Division of Baurs Healthcare. Responsible for product and technical demonstrations, documentation, technical support, installations & maintenance procedures, marketing and promotion procedures (customer collaboration), tender capital business and sales procedures of relevant products of above agencies.
Biomedical Engineer
Durdans Hospital
06.2016 - 12.2017
- Facilitated medical device installations and maintenance to ensure optimal functionality
- Performed technical evaluations and reviewed documentation to enhance compliance and operational standards
- Trained healthcare personnel on device usage
Education
Master of Science - Biomedical Engineering – specialising in medical imaging
Technical University of Denmark
Lyngby 2800, Denmark01-2021
Bachelor of Science (Hons) - Biomedical Engineering
General Sir John Kotelawala Defence University
Ratmalana, Sri Lanka01-2017
Skills
Strong analytical and structured thinking in QA and risk management
Ability to define clear and defensible QA positions in complex situations
Trusted advisor for standards interpretation and compliance decisions
Proven ownership of high-impact QA topics across development projects
Strong communication skills in translating regulatory requirements into practical solutions
Focus on risk-based decision-making, audit readiness, and long-term quality improvement
Certification
Risk Management for Medical Devices & ISO 14971:2019 - Medical Device HQ
Additional Information
Publications
- Non-invasive Intravascular Pressure Gradient Estimation using Synthetic Aperture Ultrasound Non-invasive Intravascular Pressure Gradient Estimation using Synthetic Aperture Ultrasound - IEEE International Ultrasonics Symposium 2021
Laboratory Experience with Radioactive isotopes and ionizing radiation & protection
- Ionizing radiation detection and statistics
- Absorption of Alpha, Beta and Gamma radiation
- Identification of unknown radionuclides
Extra-Curricular Activities
Cricketer at FREM Cricket Club, Valby 2450, Denmark Cricketer at FREM Cricket Club, Valby 2450, Denmark
Interests
Interest in medical technology and innovation
Analytical problem-solving and systems thinking
Continuous learning and professional development
Timeline
Cybersecurity in Medical Device Lifecycle - GBA Key2Compliance
12-2024
Advanced Risk Management for Medical Devices and ISO 14971:2019 - Medical Device HQ
08-2024
Software Development for Medical Devices and IEC 62304 - Medical Device HQ
12-2022
Design Control for Medical Devices - Medical Device HQ
06-2022
Safety for Electrical Medical Devices and IEC 60601 - Medical Device HQ
03-2022
Risk Management for Medical Devices & ISO 14971:2019 - Medical Device HQ
10-2021
Quality Management Research & Development Engineer
Ambu A/S
09.2021 - Current
Product & Application Specialist – Medical and Surgical Devices
A. Baur & Company (Pvt.) Ltd.
01.2018 - 01.2019
Biomedical Engineer
Durdans Hospital
06.2016 - 12.2017
Bachelor of Science (Hons) - Biomedical Engineering
General Sir John Kotelawala Defence University
Master of Science - Biomedical Engineering – specialising in medical imaging
Technical University of Denmark