Quality Engineer II Job Description
We are seeking a Quality Engineer II to join our team at {company}. The successful candidate will have 3+ years' experience in Quality and Regulatory control of medical devices.
Key Responsibilities:
* Ensure product quality during early development phases through to commercial launch.
* Support the Quality Management System (QMS) batch release, internal audits, and supplier management.
* Develop and implement quality engineering activities, including test reporting, batch release, first article inspections (FAI), data collection for sample testing, and supplier qualification and evaluation processes.
Requirements:
* Background in quality engineering, with expertise in quality assurance, quality control, and regulatory compliance.
* Strong knowledge of quality management systems, including ISO 13485 and FDA regulations.
* Excellent communication and problem-solving skills, with the ability to work effectively in a team environment.
What We Offer:
* A dynamic and supportive work environment.
* Opportunities for professional growth and development.
* A competitive salary and benefits package.