Quality Engineer Job Description
", "
We are seeking an experienced Quality Engineer to provide technical leadership and support to our production, quality control, purchasing, facilities, IT, regulatory, analytical lab, research and development, and engineering sustaining teams.
", "
", "
* Provide technical leadership and guidance to ensure compliance with relevant procedures and regulations.
", "
* Manage and drive project activities to ensure timely completion of project milestones.
", "
* Represent the team at key review meetings and build effective relationships with other functions.
", "
* Lead in the area of FDA, QSR, and ISO13485 requirements and promote awareness of best industry practice.
", "
* Identify and implement opportunities for improvement and maintain a proactive approach to developing our Quality system.
", "
", "
Required Skills and Qualifications
", "
To be successful in this role, you will need:
", "
", "
* A third-level qualification in Science, Engineering, or a relevant technical discipline.
", "
* Proven knowledge and experience of working with ISO13485, ISO14971, EU Medical Device Regulation 2017/745, and the FDA QSR including 21 CFR Part 820 and 21 CFR Part 11.
", "
* Excellent communication and inter-personal skills.
", "
* Proven track record of pursuing continuous self-improvement.
", "
* Good working knowledge of Microsoft Office.
", "
", "
Benefits
", "
This is an exciting opportunity to join our team and contribute to the success of our organization. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.
", "
Others
", "
Please note that this job description is not an exhaustive list of responsibilities. You may be required to perform other duties as necessary.
",