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Technical Expert

ID: 3624

Type: Full-time

Category: Others

Company Name: Kiwa

Location: Woerden

Salary: 5200 - 5200 EUR MONTH

Education Level: HBO

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Job Description

Function Testing

Job type Hybrid

Working hours 32 - 40

Job Summary

As a Technical Documentation Reviewer, you play an essential role in assessing the safety, performance and compliance of innovative medical devices according to the MDR. Kiwa has a focus onSoftware as a Medical Device (SaMD) and AI-enabled technologies for innovative SME's. Your expertise contributes directly to bring safe and innovative devices to the patient.

About the role

In this position, you independently perform technical documentation assessments and support certificationprocess.Kiwa supports a hybrid working environment, after your start-up period, you will work one day per week from our office in Woerden, while the remaining days can be performed from home. You will occasionally travel within Europe for unannounced audits as a technical expert. Regular audits are performed by our lead auditors (other role).

Key Responsibilities:

- Review SaMD and AI documentation including Regulation (EU) 2024/1689;

- Perform end-product verification and review PMS/ PSUR's results;

- Keep your knowledge up-to-date and share with your colleagues during the monthly knowledge sharing sessions;

- Guide trainee and junior reviewers;

- Final review of certification activities (based on experience).

Do you have what it takes?

You are an experienced reviewer with strong analytical skills.

Requirements:

- Completed degree in engineering, medicine, computer science or similar;

- 3+ years technical file review experience at a Notified Body;

- SaMD experience and MDA 0315 competence;

- Knowledge of lifecycle processes and ML principles;

- Fluent in English;

- You are living in the Netherlands.

What can you expect from us in return?

- "Enjoy your work as part of an enthusiastic and highly motivated team.

- Salary between €5.200,- & €6.300,- depending on experience and knowledge, with growth potential;

- 30 days paid leave;

- Secondary benefits including lease bike and pension;

- Laptop, phone and necessary tools;

- Training and education opportunities.

About Kiwa

Kiwa is a global leader in TIC services with a mission to improve safety, quality and sustainability.

Team Description

You will join a supportive and improvement minded, team with high expertise and different nationalities. We stay close to our SME customers while keeping our impartiality and independency.

Application Procedure "After receiving your application, we will contact you within five working days. If we are enthusiastic about your profile, we will invite you for a first interview. If you have any questions about the vacancy, feel free to reach out to our Recruiting Business Partner, Denise Rust, at or send a WhatsApp message or call .

"

Opleidingsniveau: HBO
Carrièreniveau: Ervaren
Uren: 32 - 40 uur per week
Company Information

Company Name: Kiwa

Company Website: https://www.kiwa.com

Company Address: N/A

Kiwa is a global testing, inspection and certification (TIC) organization headquartered in the Netherlands that provides independent technical assessment and assurance services to private- and public-sector clients across a broad set of industries. According to the company's public materials, Kiwa delivers product testing and certification, management‑system certification, inspection services, laboratory analysis, calibration, consultancy, and training designed to help manufacturers, utilities, contractors, developers and public authorities demonstrate regulatory compliance, improve product and system performance, reduce risk and support sustainability objectives. Kiwa’s core business activities center on conformity assessment and technical assurance. The company operates accredited testing laboratories and certification bodies that perform type testing, performance verification, materials and component analysis, chemical and microbiological testing, and mechanical and electrical safety testing. Kiwa carries out conformity assessment and certification of management systems such as quality, environmental and occupational health & safety systems and issues product and component certificates where applicable to demonstrate compliance with relevant national, regional and international standards and industry specifications. Inspection services include on‑site inspection of installations, factories, pipelines and civil works, periodic surveillance inspections, third‑party verification of construction and commissioning activities, and condition assessment of assets in service. Kiwa serves a wide range of market sectors. Historically active in water and utilities, the company’s services extend into energy and renewables, building and construction, industrial manufacturing, oil & gas, automotive and transport, food and agriculture, healthcare products and services, and environmental services. For utilities and infrastructure clients, Kiwa provides services such as water quality testing, drinking-water system compliance, pipeline and gas network inspection, metering and smart meter verification, and asset integrity inspections. In the built‑environment and construction sectors Kiwa supports product type approval, construction product testing, on‑site inspection and certification of systems and materials, and compliance checks tied to national building regulations. Product and systems testing is a major focus: Kiwa performs laboratory evaluations and field tests to assess safety, performance, durability, reliability and environmental characteristics of components and finished products. Typical product work includes mechanical and electrical safety testing, pressure and leakage testing for pipes and fittings, material composition and corrosion testing, and functional performance testing for equipment such as pumps, valves, meters and control devices. The organization also supports testing and certification for products and systems used in energy generation and distribution, including services relevant to photovoltaic equipment, battery storage, and charging infrastructure for electric vehicles where regulatory and standards assessments are required. Beyond testing and inspection, Kiwa provides technical consultancy and training aimed at improving operational practices and supporting compliance programs. Its consultancy services include risk assessments, failure investigations, lifecycle and asset‑management advice, regulatory compliance consulting, and assistance with conformity assessment routes for new products entering regulated markets. Training offerings cover both technical and management topics such as quality management systems, inspection and testing methods, regulatory awareness, and sector‑specific competency development for engineers and technical personnel. Kiwa emphasizes the role of accredited assurance in its service delivery. The company’s laboratories and certification bodies operate under accreditation from national accreditation bodies and apply international standards for testing and certification to ensure impartiality, traceability and repeatability of results. Kiwa’s accreditation and conformity‑assessment activities enable customers to demonstrate compliance with standards and regulations in domestic and export markets and to obtain recognized certificates required by regulators, public procurers and commercial partners. In response to market trends, Kiwa has expanded its portfolio to include digital and data-driven services intended to support smart infrastructure and product lifecycles. These offerings can include testing and verification of metering and sensor devices, conformity assessment for connected products (IoT), and services that help customers manage data integrity, interoperability and long‑term maintenance of digitally enabled assets. The company also describes activities linked to sustainability verification, energy performance assessments and support for clients implementing greener technologies and circular‑economy practices. Kiwa’s typical clients range from manufacturers and product developers that require independent testing and certification prior to market entry, to utilities and infrastructure owners seeking inspection and asset‑management support, to public bodies requiring impartial conformity assessments for tenders and regulatory compliance. Its work often interfaces with standards bodies and regulators, and Kiwa positions itself as a partner that helps organizations translate technical and regulatory requirements into operational compliance and demonstrable product or system performance. The company publishes details of its scope of accreditation, testing capabilities and sector‑specific services on its official website and through regional Kiwa business units. Kiwa highlights impartiality, technical competence and accredited methods as central to its approach, and it offers multi-disciplinary teams combining laboratory scientists, engineers, auditors and industry specialists to deliver its services. For organizations facing product compliance, safety, reliability or sustainability challenges, Kiwa’s combination of laboratory testing, field inspection, certification and advisory services is intended to provide an integrated route to independent assurance and market acceptance.
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