Strengthen Our Team with a Sr. Quality Assurance Engineer
About Us
Aktiia is an early-stage, venture-backed start-up that has revolutionized cardiovascular health monitoring by providing patients and physicians with a deeper understanding of blood pressure patterns.
We have developed and brought to market the world's first continuous blood pressure monitor, backed by 15 years of research at the prestigious Swiss Center for Electronics and Microtechnology (CSEM). Our solution has been validated through extensive clinical trials and received a CE Mark as a Class IIa medical device under MDR, enabling commercial access in approximately 43 countries worldwide.
About the Role
We are seeking a highly motivated Sr. Quality Assurance engineer with expertise in operations, logistics, and manufacturing. The ideal candidate will provide leadership in corrective and preventive action, manufacturing process controls, supplier management, QMS process assurance, quality system requirements, and process monitoring.
Responsibilities:
* Partner with manufacturing teams 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.
Requirements
* 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.
What We Offer
* 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.