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Ensures site activities associated with medical device manufacturing and testing comply with quality management systems and applicable regulatory requirements. Coordinates Quality Management Systems ensuring compliance to all relevant regulations and standards including FDA QSR Part 820; including change management, record retention, training, and assist with the internal audit program.
Collaborates with customers, business, and development teams to analyze business requirements and functional specifications to identify risks and issues and proposes solutions. Establishes and maintains continual improvement of systems that impact Research and Development and Commercial operations of the organization.
Under general direction, creates and modifies new and existing software involved in full system life cycle and is responsible for coding, testing, implementing, maintaining, supporting application software, and mentoring Software Developers
Under general direction, creates and modifies new and existing software involved in full system life cycle and is responsible for coding, testing, implementing, maintaining, supporting application software, and mentoring Software Developers
