Would you like to be part of our inspiring team who is dedicated to innovate surgery by developing a microsurgical robot device?
Are you looking for a job where you can make an impact and where your ideas will be appreciated?
WHY WE NEED YOU
The Quality & Regulatory Engineer is an important role within Microsure.
You share responsibility for ensuring that Microsure operates and complies with international medical device related standards, regulations, local laws, policies, and other legal requirements. You are the driving force in guiding the organization to a higher level of compliancy.
YOUR KEY TASKS
- Implement scientific, legal and regulatory documents in the organization
- Gather and evaluate process information in a variety of formats
- Closely involved and working together with various (internal and external) project teams
- Ensure the deliverables from projects are in line with Microsure’s Quality Management System
- Ensure training for employees in using templates/guidelines/SOPs
- Verification and reviewing project deliverables
- Independent design reviewer
- Auditor for internal processes
- CAPA process coordinator
- Ensure compliance with all relevant regulatory legislation and guidelines.
- Coordinate product verification trials and regulatory/quality inspections
- Outline and implement design requirements in the organization (e.g. labeling, storage)
- Interact in quality/supplier audits
- Support in notified body submissions and technical file compilation
- Prepare quality and regulatory relevant documentation
- Act as a backup for PRFRC
- Support QR manager with implementation and continuous support the QMS
You are a result minded Quality & Regulatory Engineer who likes to get things done in a friendly, hardworking, international start-up environment. Your opinion is much appreciated as you act like a sparring partner for the Quality & Regulatory Manager. You do not shy away from reminding and holding your colleagues accountable for their responsibilities to work according to the expectations of a highly regulated industry.
- Vocational College or Bachelor degree in technical oriented study
- At least 3 years of relevant working experience in Quality Assurance or Quality Management
- Internal auditor experience under ISO 13485 or ISO 9001
- Risk management skills under ISO 14971
- Basic clinical research knowledge
- Basic GDPR knowledge
- Driver’s license
- Strong personality with persuasiveness and drive
- Able and willing to create and maintain companywide quality awareness
- Team player
- Hands-on way of working
- Excellent communication skills in English (written and spoken)
- Enthusiasm for working in a start-up environment with dynamic requirements
- Positive attitude, can-do mentality, and flexible
We welcome you to a challenging part-time job.
- 32-40 hours per week
- Flexibility in working hours and work location (hybrid)
- Competitive salary
- Stock Option plan
- 25 holidays (fulltime), with option to buy up to 10 (fulltime) additional days
- Stimulating innovative environment with great opportunities for growth
If you are interested, please submit your application with motivation and CV to email@example.com
For additional information feel free to contact René Wenmekers (Quality & Regulatory Manager) firstname.lastname@example.org.