We're looking for an experienced Senior Quality Assurance Specialist to join a leading medical device organization. This position will be responsible for providing oversight and ensuring that manufacturing and operations processes meet all applicable regulatory and GMP requirements, including 21 CFR Part 820 and ISO 13485. You will be the go-to expert for maintaining quality systems, reviewing production batch records, and making critical quality decisions. As part of the team, you'll play an essential role in driving quality and compliance throughout the operations.