QA/QC Manager - Medical Product Manufacturing

QA/QC Manager – Medical Product Manufacturing

A medical product manufacturer seeks a manager in Quality Assurance department.

 

The individual will participate in regulatory affairs and in all activities to maintain quality management system.  It includes the following duties: Maintain current ISO 9001 and ISO 13485 quality systems. Prepare and implement procedures for quality improvement. Write and implement QC test procedures and protocols Monitor performance of test equipment and schedule calibrations Write GMP and ISO documents related to product development, manufacturing and quality assurance, SOP's, MSDS and technical bulletins.  Participate in preparing 510(k) submissions, and response to appropriate government agencies. Provide regulatory support for new product development. Participate in product registration activities in other countries. Assist in resolving customer's technical issues with existing products.




Requirements: Bachelor degree in chemistry, bioscience or medical engineering and previous experience in regulatory affairs, QA/QC is necessary. Experience in medical product manufacturing is a plus.

 

The company is conveniently located in Queens, close to NYC subways and LIRR.

 

Please, e-mail resume with salary requirements to hr2chemistry@yahoo.com