Quality System Engineer

Fikst, a Re Manufacturing company, is seeking a Quality System Engineer to lead their quality management system. The ideal candidate will have at least 5 years of experience in managing quality systems, specifically in the medical device or regulated industry, with a strong background in ISO 13485.

Key responsibilities include:

• Leading the quality management system (QMS) in accordance with ISO 13485
• Managing compliance with regulatory and statutory requirements
• Driving continuous improvement in quality processes
• Collaborating with cross-functional teams to ensure product quality
• Overseeing internal and external audits
• Training and mentoring staff on quality procedures
• Monitoring and reporting on QMS performance metrics

The ideal candidate will bring:

• 5+ years of experience in quality management within a regulated industry
• Bachelor's degree in Engineering, Life Sciences, or related field
• Strong leadership and communication skills
• Technical expertise in quality management systems and regulatory audits
• Analytical mindset and problem-solving skills
• Meticulous attention to detail
• Collaborative approach and passion for mentoring

Fikst offers a unique opportunity to work with pioneering clients and develop cutting-edge products. As part of Re Manufacturing, the company is committed to rekindling America's manufacturing base and creating meaningful, sustainable jobs. Employees share ownership in the company and participate in its financial success.

Join Fikst to make a significant impact in the product development and manufacturing industry while working in a dynamic, innovative environment.