As a Quality Manager you are responsible for the quality assurance and regulatory compliances. You monitor the quality of our products day-to-day and implement guidelines and improvement regularly.
For EU market, Medical device regulation (MDR) and ISO 13485 are the key to follow. Other regulatory requirements must be complied when entering new market such as US market.
Matrixreq and Odoo ERP are the main software tools we use to ensure quality.
Responsibilities
- Improve quality and QMS in general
- Provide quality plan and improve procedures
- Provide guidance on risks assessment
- Follow up on nonconfomities and CAPA
- Peform internal audit
Must Have
- MSc in Mechanical or Electrical Engineering
- 4+ years in Quality Assurance field
- Strong communicaiton skills in English
- Leadership
- Very good English writting
- Good knowledge on ISO 13485
- Good knowledge on MDR
- Good knowledge on FDA
Nice to have
- Familiar with design and development of medical electrical equipment
- Familiar with Software life-cycle management
What's great about the job?
- Great team of smart people, in a friendly and open culture
- No dumb managers, no stupid tools to use, no rigid working hours
- No waste of time in enterprise processes, real responsibilities, and autonomy
- Expand your knowledge of various business industries
- Real responsibilities and challenges in a fast-evolving company
What We Offer
Each employee has a chance to see the impact of his work. You can make a real contribution to the success of the company.
Perks
A full-time position
Attractive salary package.
Trainings
Training can be obtained whenever is needed.
Bonus Scheme
Performance based bonus/stock options.
Activity
Company outing, weekly drinks.
