Principal Quality Systems Engineer

Support internal and external audits and audit responses to existing products. Manage quality systems core within an integration project. Support CAPA (Corrective and Preventive Actions) and nonconformance processes. Provide PMPC (Product Manufacturing Process Control) support. Minimum of 7 years of experience in medical device quality systems. Bachelor's degree in science, health, or engineering Understanding of design control and risk management. Understanding of US and International regulations including 21 CFR, 820, and ISO 13485 is required, as well as the Medical Device Directive, EUMDR, and EN ISO 14971. Familiarity with US and international regulations. Strong communication and presentation skills. Strong project management skills (preferred but not mandatory). Proficiency in Microsoft Office suite and Windchill. Ability to work with internal systems and external candidates. Experience in managing quality systems within integration projects. Ability to work independently and as part of a team. Strong problem-solving skills and attention to detail.