Our client, a global leader in the orthopaedic-medical technology market, is in search of two Quality Assurance Engineers to join their design team. The QA Engineer will promote and enhance quality policy and quality systems. Provide QA support to all processes. Guarantee compliance to applicable regulations, procedures, standards, regulations.
Essential Duties & Responsibilities
ˇ Stand as independent QA reviewer along NPI
ˇ Stand as independent QA reviewer of Customs dossiers.
ˇ Complete appropriate review of customs DHF/DMR or supervise designated subordinates to complete the review.
ˇ Complete final QA release of customs or supervise subordinates designated to complete it.
ˇ and more...
Desired Experience
ˇ Knowledge of regulations/standards/directive applicable to spinal implants, instruments, and human tissue products (ISO13485, 21CFR820, 21CFR1271, 93/42/CE, cGMPs)
ˇ Basic notion on Japanese, Canadian regulations
