Quality Systems Analyst (Engineer)

Purpose: The individual will be responsible to manage the internal audit program within the Quality Systems group. This includes scheduling, execution, reporting, follow-up, and corrective action completion. The Quality Systems Analyst will develop/update procedures, manage corrective and preventative action system (CAPA), and work closely with various disciplines (including Quality, Engineering, Manufacturing, and others). Individual will be expected to use their regulatory knowledge along with outstanding presentation skills to provide quality system training for the Company as well as guide in the interpretation of regulations/standards to working practice.

Qualifications: BS in Engineering or Science required with a minimum of 5-7 years work experience. To be successful in this role, the individual must have solid knowledge and experience in regulated environment, able to work with a minimum of supervision and have a working knowledge in ISO 13485 and/or FDA Medical Device Regulation. Must have excellent presentation skills both written and verbal as the role requires that the individual will be responsible for representing the company during external audits by outside agencies. Individual must be a trained Quality System Lead Auditor.

Qualified candidates please send resume and references to