Description
Reporting to the Director Quality, the Quality Manager will assume responsibility for the day-to-day quality functions Including:-Managing quality activities related to commercial production e.g. Final Inspection, Lot Release, Sterilization, Production Support, Complaints, RMAs
-Managing incoming inspection and equipment control activities
-Providing quality engineering support activities for production and new product development actitivies.
-Implementation and maintenance of quality assurance standars, methods and procedures as well as quality control systems
- Ensure the precision, accuracy and reliablity of the company's medical device products in accordance with applicable federal and international regulations and standards, e.g. FDA's Quality System Regulation (QSR), and ISO EN 13485
-Support document control systems, internal compliance audits, and participate in vendor and service supplier selection
-Support third party audits e.g. ISO, FDB,FDA
-Perform regular production audits and audit production documentation
-Execute work in a manner compliance with FDA and ISO guidelines for medical device development and manufacture
-Maintain compliance with all document and procedure training requirements
-Develop,refine,validate test methods
REQUIRED:
8+ years medical device (CLASS III) experience in quality assurance with progressive management responsibilities
Excellent written and oral communication skills with a demonstrated track record of strong organizational and interpersonal skills
Experience with Quality Systems implementation and maintenance;statistics; GMP/Quality Systems Regulations; 21CFR820//ISO13485//MDD
Experience in both R&D and Manufacturing environments
To find out more about Real Staffing please visit www.realstaffing.com