We are seeking a highly skilled and motivated Quality Assurance
Engineer with a strong background in technical writing and experience
within the medical device industry.
collaborate with cross-functional teams to establish, maintain and improve
the SDLC in accordance with relevant regulation (ISO 14971 21CFR820 IEC 62304)
Develop and maintain detailed and accurate technical documentation
Ensure that design Development documentation complies with industry standards and regulatory guidelines.
In charge of risk management according ISO 14971 and internal
stay up-to-date with relevant regulations and standards ensuring the companys with changing requirements.
Ensure that validation activities are properly documented and meet regulatory expectations.
***The position is intended for both women and men***