Job details

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.

Average salary estimate

$95000 / YEARLY (est.)

min

max

$80000K

$110000K

If an employer mentions a salary or salary range on their job, we display it as an "Employer Estimate". If a job has no salary data, Rise displays an estimate if available.

What You Should Know About Sr. Quality Engineer - Operations, Aktiia

At Aktiia, we're on a mission to revolutionize cardiovascular health by empowering patients and healthcare professionals with innovative solutions. We're excited to announce that we're looking for a Sr. Quality Engineer - Operations to join our dynamic team. In this vital role, you'll leverage your expertise in quality assurance to enhance our manufacturing processes and ensure that our groundbreaking continuous blood pressure monitor meets the highest standards of quality. Your responsibilities will involve collaborating closely with our manufacturing partners, heading up efforts on non-conformance resolutions, and leading cross-functional teams through the CAPA process. With your proficiency in regulatory requirements like ISO and FDA guidelines, you'll help strengthen our quality management system and drive operational efficiency. We value creativity and leadership highly; as our Sr. Quality Engineer, you’ll mentor team members and ensure compliance with comprehensive GMP and QMS standards. At Aktiia, flexibility is key—whether it's juggling multiple tasks or adapting to changing priorities, your ability to work autonomously and effectively will be greatly valued. Join us to contribute to a product that impacts lives and be part of an early-stage venture that is rapidly growing. Enjoy a competitive salary, a flexible hybrid work arrangement, and the chance to make a tangible difference in the healthcare world with us. We can’t wait to see how you can enhance our mission!

Frequently Asked Questions (FAQs) for Sr. Quality Engineer - Operations Role at Aktiia

What are the main responsibilities of a Sr. Quality Engineer - Operations at Aktiia?

As a Sr. Quality Engineer - Operations at Aktiia, your primary responsibilities include leading quality engineering activities with contract manufacturers, managing non-conformance resolutions, supporting CAPA processes, and ensuring compliance with regulatory standards such as ISO and FDA. You will also coach manufacturing personnel on GMP and QMS requirements, document product-related vigilance reports, and oversee supplier management activities.