Quality Engineer

Company Description

At Nicolab we connect the physicians and streamline their emergency care workflows, providing physicians with AI-analyzed scans and centralized patient information.

We currently are..

• Operational in 10+ countries across 4 continents

• Established presence in Europe and Australia

• Quickly expanding to China, Middle East and the rest of Europe and Australia

• 30+ employees across the world, with an office in Amsterdam and Australia

Role Description

We are looking for a Quality Engineer who will strengthen and maintain the quality of our product and related QMS processes, in accordance with the relevant standards and regulations, including but not limited to the European Medical Device Regulation (MDR), ISO 13485, ISO 14971 and ISO 62304.

As Quality Engineer, you will oversee and ensure the compliance of software development processes, including software releases. You will be key in continuously improving existing and new processes, introducing efficiencies and optimizing workflows. Furthermore, you will own risk management processes related to our products, ensuring their continued safety and performance. You will be the go-to person for all things Quality Engineering, providing training and leadership to other roles within Nicolab.

Key Responsibilities

• Maintain Quality of the product and product related QMS processes

• Risk management products

• QMS process Software development leadership

• QMS process Product release leadership

• Training of Engineering staff on QMS processes

• Error Monitoring and escalation, & Hotfix management

• Project manager Engineering NCs and CAPAs

• Release testing (development, update, automation & execution)

• Non-medical device quality process

• Support of (medical device) product development including testing, requirements management, risk management, documentation (architecture, technical file) for regulatory submissions and maintenance

• QMS audit support (internal & external)

• Workflow development, documentation and automation in Jira

• QMS software validation

Qualifications

• Strong expertise experience with ISO 13485, ISO 14971, ISO 62304 and preferably MDR;

• Proficient in Quality Engineering and Quality Control methodologies

• Experience with Quality Assurance processes and procedures

• Strong understanding of Product Quality and Quality Management principles

• Familiarity with quality frameworks, tools, and regulatory compliance standards

• Exceptional analytical and problem-solving skills

• Strong communication in English and collaboration abilities

• Bachelor’s degree in engineering, quality management, or a related field

• 3+Years experience in healthcare technologies or medical software development is a plus

Benefits

• Chance to make a real difference in patients' lives

• Work in a stimulating environment with a motivated team

• Flexible Employment Agreement: Part time / Fulltime / Remote (EOR Contract*)

• Flexible working hours

• Flexible paid time off*

• Remote work policy

• Laptop + home office/IT equipment*

• Commuting to work/office* - costs reimbursement

• Pension plan scheme*

• Employee Stock Option Plan (ESOP)*

• Corporate programs including Employee Referral Program with rewards

• Learning & Development opportunities including in-house training and coaching, professional certifications, and over 22,000 courses on LinkedIn Learning Solutions and much more

*All benefits and perks are subject to certain eligibility requirements based on location

Application Process

• Interview with Recruiter/HR

• Interview with Future Manager (hiring manager)

• Technical assessment with Peers (no managers present)

• Prior employment verification check (reference/background check)

• Interview with Executive