A small-scale medical device organization based in Chelmsford, MA that focus on plastic injection molding has focused their efforts on brining in a Manager of QARA on a full-time basis.

This individual is expected to come in and lead the entire QARA team, incorporating responsibility for activities in which the company will uphold it's regulatory compliance.

The main responsibilities of the role are listed below but are not limited to:

• Lead development, implementation and management of the QMS.
• Work on PPAP requirements of customers, as well as implementing quality-based efforts to manufacturing and sterilization.
• Smooth the way for external Quality System audits and guide the department through any upcoming FDA inspections.
• Provide expertise on FDA submissions.
• Spearhead the QARA department's work towards US and EU regulatory requirements.

Various levels of preferred experience is listed below:

• 5 Years' of experience within the field of medical device or injection molding industries.
• Preferred but not required would be any experience working amongst polymers, biology or metrology.
• Experience in writing standard operating procedures and knowledge and experience working to international and state laws and regulations such as ISO 13485 & FDA QSMR.

Interested in learning more? Apply to Andrew Willoughby at X4 Life Sciences at a.willoughby@x4lifesciences.com