QA/QC, Regulatory Affairs Manager - medical products

QA/QC Manager – Medical Product Manufacturing

 

Propper Manufacturing is a Queens based manufacturing company which has been in existence for over 70 years.  It has always been and continues to be a leader in the sterilization and medical laboratory fields.  The Company is now seeking a QA/QC leader to become a key part of the new management team. Propper values its employees and offers attractive employee benefits including health insurance, Section 125 benefits plan, subsidized health club membership, employee wellness campaign and various Company funded employee activities. 

 

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. Previous experience in regulatory affairs, QA/QC is necessary. Experience in medical product manufacturing is a plus.

 

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

 

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