Sr. Quality Engineer - Operations

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, and manufacturing (complaints handling is a plus):

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 orders.
• Coach mfg. personnel and contract manufacturers on GMP and QMS requirements for medical device manufacturers.
• Lead projects to drive product improvement and increase operational efficiency at the direction of quality management.
• Support internal labeling reviews to ensure required markings and symbols are present on product labels and in the user manual.
• Lead supplier management activities (e.g. supplier audits, qualifications, assessments).
• Support QMS audits with both internal and external auditors
• Document product related vigilance reports within the required timelines and provide any necessary documents required to complete the investigation.

• Bachelor’s degree in a technical or scientific field.
• 5 - 8 years minimum experience in a quality or manufacturing function in the finished medical device industry.
• Demonstrate team leadership skills and ability to independently prioritize, execute and report on projects.
• Knowledge on ISO and FDA/Quality System Requirements. (e.g. MDR; ISO 13485; ISO 14971; FDA 21 CFR Part 820)
• Strong project and time management skills
• Familiar with Risk Management as governed by ISO 14971 (e.g. process FMEA)
• Demonstrate creative and effective problem solving for resolving complex issues.
• Ability to work on multiple tasks concurrently with changing priorities
• Proficient with MS Teams, Word, Excel, PowerPoint, and eQMS systems.

• Competitive compensation package based on experience.
• Flexible work location (hybrid work schedule) and occasional international travel as required (10% of time)

We look forward to receiving your application on the platform or at aktiia@jobs.workablemail.com.