Sr. Quality Engineer - Operations

Early-stage startup that developed the world's first continuous blood pressure monitor, backed by $40M venture funding.
Neuchâtel, Switzerland
DevOps
Senior Software Engineer
Hybrid
11 - 50 Employees
5+ years of experience
Healthcare · Biotech

Description For Sr. Quality Engineer - Operations

Aktiia is revolutionizing cardiovascular health monitoring with the world's first continuous blood pressure monitor. As a venture-backed startup with over $40M in funding from top-tier investors across Europe and the United States, we're at the forefront of medical device innovation. Our technology, built on 15 years of research at the Swiss Center for Electronics and Microtechnology (CSEM), has achieved CE Mark certification as a Class IIa medical device under MDR, enabling commercial access in approximately 43 countries worldwide.

As our Sr. Quality Engineer - Operations, you'll play a crucial role in maintaining and improving our quality standards across manufacturing and operations. You'll work at the intersection of development, operations, and manufacturing, ensuring compliance with medical device regulations while driving continuous improvement. This position requires expertise in corrective and preventive action, manufacturing process controls, supplier management, and quality system requirements.

The role offers a unique opportunity to impact global healthcare by ensuring the quality and reliability of innovative medical devices. You'll lead cross-functional teams, work with contract manufacturers, and drive quality initiatives that directly affect product excellence. With our hybrid work model and international presence, you'll enjoy flexibility while contributing to a mission-driven organization that's changing how we monitor cardiovascular health.

If you're passionate about quality engineering in medical devices, have strong leadership skills, and want to be part of a growing startup that's making a real difference in healthcare, this role offers the perfect blend of challenge and opportunity. Join us in our mission to improve cardiovascular health monitoring and make a lasting impact on patient care worldwide.

Last updated 3 months ago

Responsibilities For Sr. Quality Engineer - Operations

  • Partner with manufacturing team to lead/support quality engineering activities with contract manufacturers
  • Lead cross-functional teams to resolve quality issues and navigate the CAPA process
  • Resolve manufacturing non-conformances with contract manufacturers
  • Coach manufacturing personnel on GMP and QMS requirements
  • Lead projects to drive product improvement and increase operational efficiency
  • Support internal labeling reviews
  • Lead supplier management activities
  • Support QMS audits
  • Document product related vigilance reports

Requirements For Sr. Quality Engineer - Operations

  • Bachelor's degree in a technical or scientific field
  • 5 - 8 years minimum experience in quality or manufacturing function in medical device industry
  • Team leadership skills and ability to independently prioritize
  • Knowledge of ISO and FDA/Quality System Requirements (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
  • Creative and effective problem solving skills
  • Proficient with MS Teams, Word, Excel, PowerPoint, and eQMS systems

Benefits For Sr. Quality Engineer - Operations

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

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