Quality Engineer

Fort Wayne, Indiana area company is seeking a Quality Engineer experienced in the Medical Device arena

Qualified candidates must have strong technical & analytical skills including understanding of technical drawings and documents, excellent organizational, leadership and delegation skills, and outstanding communication skills.

This position requires a team-focused individual who is adept at multitasking with excellent responsiveness capabilities.  Primary function will be to lead the quality function in conjunction with product development, and regulatory/business plan development.  Position will encompass the following responsibilities:   

Quality system overall leadership, process development and system maintenance
Identify opportunities for improvement across all quality and business functions.
Develop, certify, and maintain supplier quality development and scorecard systems.
Facilitate CAPAs and track customer issues
Spearhead validation of existing and new products
Support in new product development
Management of calibration activities and inspection processes

Qualifications

Must have experience with ISO 13485 standards and FDA regulations in a medical device industry.
Understanding of parts marking and FDA UDI compliance within the medical device industry.
Project Management experience
Process validation and product inspection experience in a medical device industry.
Supplier development and qualification program experience.

Excellent salary and benefits package

Contact Information

Name: Karin Reid
Phone: not published
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