This is not an ordinary run of the mill testing job. This is not a job for people who are scared of learning and challenges! We are looking for people with a passion for testing and solving technical problems from a quality and testing perspective. This is a hands-on role that requires the test specialist to deliver and not delegate. We need individuals who will be eager to become product experts, with the skills to be a shrewd investigator, a resourceful problem-solver, and a supportive team member. The test team is quickly becoming a hub of technical information that is sought by the design teams and the support teams; we want you to help us maintain that reputation. Are you up for the challenge?
Senior Technical Specilaist
Application Developer (Plan)
Application Developer (OPTICS)
We are seeking an experienced Product Surveillance/Complaint Specialist. Working under general supervision, the Specialist receives, reviews, evaluates, investigates, and resolves medical device complaints. Maintains quality documents to ensure compliance with various regulatory agencies. Analyzes complaint data and trends. Coordinates the resolution of complaints and ensures that timely investigations are performed. Provides feedback to the development, manufacturing, and quality teams on potential product improvements for medical products. Prepares and files Medical Device Reports as appropriate to the U. S. Food & Drug Administration (FDA) and Health Canada (HC). Generates customer letters upon completion of investigation as appropriate.
Planning and designing environmental sampling and analysis work plans, developing standard operating procedures, regulatory compliance oversight, senior review, senior technical advice, technical lead, directing complex site assessment work, making recommendations, preparing reports, evaluating multiple lines of evidence.