At Aktiia, we believe the key to improving cardiovascular health is to provide patients and physicians with a deeper understanding of the blood pressure pattern. Before Aktiia, it was not possible to monitor cardiovascular health at scale.
We are an early-stage, venture-backed start-up that has raised over $40M from top-tier investors in Europe and the United States. We have developed and brought to market the world's first continuous blood pressure monitor. Our technology is based on 15 years of research by our founders at the prestigious Swiss Center for Electronics and Microtechnology (CSEM). Aktiia's solution has been validated through extensive clinical trials and received a CE Mark as a Class IIa medical device under MDR leading to commercial access of approximately 43 countries worldwide.
To strengthen our team, we are seeking a highly motivated Sr. Quality Assurance engineer with experience in operations, logistics, hardware design, and manufacturing:
This position must provide expertise and leadership in the areas of corrective and preventive action, manufacturing process controls, supplier management, QMS process assurance, quality system requirements and process monitoring. This position will work with Development, Operations, Manufacturing, and other Quality functional areas to ensure work is completed in accordance with internal procedures and medical device regulations. In addition, this role must be flexible for changing priorities and able to work without direct supervision.
Responsibility:
Partner with manufacturing team to lead/support quality engineering activities with contract manufacturers (IQ, OQ, PQ support, non-conformance resolution, process validations, test method validations).
Lead cross-functional teams to resolve quality issues and navigate the CAPA process.
Resolve manufacturing non-conformances with contract manufacturers. Approve DHRs, DHF deliverables, product releases and change o...