Responsible for the regulatory affairs and Quality Assurance requirements.
To prepare, implement and maintain quality regulations
Appointed as Management representative according to the ISO13485:2016 (5.5.2)
To define the quality policy and control its implementation
Responsible to ensure that processes needed for the quality management system are
documented
Control of equipment calibration and maintenance
Continuous control of existing quality procedures and their effectiveness by means of
initiating and conducting Internal Quality Audits, and presenting the findings to the
management
Control of documentation and quality records
Analyze quality data and trends for management reviews
Affirmation that the company products fulfill the requirements for standardization and
quality
Approval of a DMR (Device Master Record) for new products
Requirements: Bachelors degree in Engineering; or over 10 years experience of Regulatory and Quality
management in the medical device industry; a minimum of three years experience in quality
control function and 3-5 years management experience; or equivalent combination of
education and experience.
ASQ ICQM certification preferred.
Experience in Process Optimization and Variability Reduction/Cost Reduction Projects or similar.
Regulatory knowledge specific to the FDA Quality system Regulations, ISO9001/ISO13485,
Medical Device Directive (MDD), Regulation MDR 2017/745 required, Japan, Canada, Australia
and other countries.
Experience in process validation, working in a production environment would be advantageous.
Proven ability of working in a cross-functional team environment.
Certified auditor for medical devices systems preferred.
This position is open to all candidates.
