Senior QA for Medtech

Senior QA Engineer (Medical Software, FHIR, ICU) – Regulated Environment (EU MDR)

Overview

We are building a FHIR-based Patient Data Management System (PDMS) for the ICU sector and are looking for a highly experienced Senior QA Engineer to ensure the quality, safety, and regulatory compliance of our clinical software product.

This is not a generic web application. It is a safety-critical healthcare product operating in a regulated environment. We are looking for someone who understands both modern software engineering practices and medical device regulatory requirements.

Long-term collaboration possible.

Your Mission

You will take ownership of the QA strategy and execution across the entire product lifecycle and ensure the integrity and quality of the clinical end product.

Responsibilities

• Quality Strategy & Governance

Define and implement a comprehensive testing strategy

Create and maintain testing documentation:

Test plans

Test cases

Test strategies

QA instruction documents

Establish and maintain the QA tooling ecosystem

Ensure QA documentation is compliant with EU medical device regulatory requirements

Prepare QA reports after each release and upon management request

Participate in design reviews and change management processes

Develop and track QA metrics and KPIs to measure product quality and testing effectiveness

• Testing Implementation & Execution

Design and oversee testing at all levels:

Component testing

Integration testing

End-to-end testing

Implement automated test coverage where applicable

Support Product and Customer Solutions teams in system validation and usability testing

Execute and document verification and validation (V&V) activities

Ensure regulatory-compliant traceability between:

Requirements

Risk analysis

Test cases

• QA Leadership

Provide technical leadership and mentorship to QA team members

Ensure strong test coverage and adoption of best practices

Collaborate closely with frontend, backend, and data science teams

Train and develop junior QA engineers

Support recruitment and team growth

• Cross-functional Collaboration

Continuously refine the test strategy with key stakeholders

Improve QA team processes:

Estimation accuracy

Sprint planning integration

Knowledge-sharing

Participate in lead meetings to coordinate workflows and quality initiatives

Work with Customer Solutions to address customer feedback and complaints in a structured way

Required Qualifications

Minimum 6 years of professional experience in software testing / quality assurance

Strong expertise in test automation

At least 2 years in a senior QA or test leadership role

Experience across the full software development lifecycle

Strong understanding of Agile development practices

Hands-on experience with modern CI/CD tools and test frameworks

Experience with test planning, design, and documentation

Strong communication skills

Experience in regulated software environments

Nice to Have

Experience in regulated industries:

Medical devices

Biotech

Automotive

Aerospace

Knowledge of EU MDR requirements for medical software

Experience with risk management in medical device development

Familiarity with:

ISO 13485

IEC 62304

Experience with healthcare interoperability standards such as HL7 / FHIR

What We Expect From You

Structured, documentation-driven thinking

High sense of responsibility for product quality and patient safety

Strong ownership mindset

Ability to operate independently

Clear and proactive communication

To Apply

Please include:

A short description of your experience in regulated software environments

Examples of QA strategies you have implemented

Details about your experience with medical device standards (if applicable)

Tools and frameworks you have used for test automation

Your availability and hourly rate

Contract duration of 1 to 3 months. with 40 hours per week.

Languages:

German, English.

Mandatory skills:

Software QA, Functional Testing

Optional skills:

Automated Testing, Manual Testing