Job Overview
Quality Assurance plays a pivotal role in ensuring compliance with industry standards and regulations. As a Quality Engineer, you will be responsible for upholding the highest standards of quality management systems.
* Develop and implement quality policies and procedures that align with ISO 13485 and FDA 21CFR Part 820 guidelines.
* Collaborate with cross-functional teams to ensure adherence to quality, environmental health and safety policies and GMP practices.
* Contribute to the enhancement of company goals and key performance indicators through data analysis and continuous improvement initiatives.
* Perform batch review and product release for sterile and non-sterile products, ensuring seamless manufacturing processes.
* Investigate non-conformances and implement corrective actions to prevent future occurrences.
* Coordinate with the NPI department to set up components and validate activities.
* Manage outsourced sterilization and laboratory activities efficiently.
The ideal candidate will report to the Quality Manager and work collaboratively with the dynamic Quality team.
The organization values entrepreneurial spirit and recognizes individual contributions. Compensation packages are based on available market data.
We collaborate with industry leaders to design and manufacture life-saving medical devices.