Would you like to contribute to the well-being of patients, by creating an innovative microsurgical robot? You could be part of our inspiring team, who is dedicated to innovate surgery by developing a microsurgical robot device.
At Microsure in Eindhoven, we are developing a new first-of-a-kind microsurgery robot. By reducing the tremor and scaling down the movements of the surgeon, we aim to provide better surgical outcome.
WHY WE NEED YOU
The Quality & Regulatory Engineer is an important role within Microsure to ensure that the company operates or complies with the standards, regulations, local laws, policies, and other legal requirements.
You are a Quality & Regulatory Engineer with an eye for detail and able to see the big picture who likes to get things done in a friendly, hardworking, international start-up environment.
YOUR KEY TASKS
- Implement scientific and legal documents and regulations in the organization
- Gather and evaluate process information in a variety of formats
- Closely involved and working together with project teams on design quality assurance activities and ensure deliverables from projects as per Microsure’s Quality Management System.
- Ensuring the new / correct templates /guidelines/SOPs are available and used.
- Verification and reviewing project deliverables.
- Independent reviewer of deliverables.
- Auditing internal processes
- CAPA process coordinator
- Ensure compliance with all relevant regulatory legislation and guidelines.
- Plan, undertake and oversee product trials and regulatory inspections.
- Outline and implement requirements in the organization (e.g. labeling, storage)
- Interact in quality / supplier audits
- Ensure quality standards are and support notified body submission
- Prepare quality and regulatory relevant documentation.
- Act as a backup for PRFRC
- Support QR manager with implementation and continuous supporting an electronic QMS
- MTS or bachelor HTS degree in technical oriented study
- Minimum of 3 years relevant working experience in Quality Assurance or Quality Management in a regulated industry
- Basic clinical research and GDPR knowledge
- Hands-on way of working and able to create and maintain companywide quality awareness
- Internal auditor experience under ISO 13485 or ISO 9001
- Risk management skills under ISO 14971
- Excellent communication skills in English (written and spoken)
- Enthusiasm for working in a start-up / scale-up environment with dynamic requirements
- Positive attitude, can-do mentality, and flexibleAffinity with our core values: We Care, We Innovate, We are Confident, We are Open, We are Diverse and Inclusive.
We welcome you to a challenging and exciting job.
- 32-40 hours per week
- Flexibility in working hours and work location (hybrid)
- Competitive salary
- 25 holidays (full-time), with option to buy up to 10 (full-time) additional days
- Stock Option plan
- Company-provided weekly fresh fruit box and a diversity of snacks
- Attractive company culture with lot of fun events
- Stimulating innovative environment with great opportunities for growth
If you are interested, please submit your application using the button below
Unsolicited responses of agencies or recruiting on behalf of Microsure without prior approval is not allowed.