Job Opportunity:
We are seeking a highly skilled Senior Design Assurance Engineer to lead our QA technical and compliance activities for the design and development of sterile and non-sterile medical devices.
This role involves Risk Assessments, Device testing and associated validation, and Audits (internal and external). You will work effectively as part of a product development team to identify and translate user requirements into design requirements, and contribute towards or lead the generation of risk management documents and associated quality documents.
The ideal candidate will have a minimum of 6 years of QA experience in the medical industry, including project management skills and leadership ability. They will also have knowledge of FDA's 21CFR Part 820 (QMSR), ISO, the European Medical Device Regulations, and other international standards and regulations.
In addition, they will be able to handle multiple tasks, operate in a fast-paced environment, and possess excellent interpersonal, written and communication skills, and proficiency in MS office products.
* Key Responsibilities:
* Risk Management
* Quality Assurance
* Project Management
* Compliance with Regulatory Standards
* Leadership and Teamwork
Benefits:
This role offers an opportunity to make a significant impact on the development of medical devices that improve people's lives. If you are a motivated and results-driven individual who is passionate about quality and innovation, we encourage you to apply.
* About Us:
* We are a company dedicated to providing high-quality medical devices that meet the needs of healthcare professionals and patients.