About Us

Daxsonics is a leading engineering consulting firm focusing on product development for medical ultrasound systems, located in Halifax, Canada. Our areas of expertise cover all aspects of high-frequency ultrasonic imaging technology: digital and analog hardware design, piezoelectric transducer design and production, and medical imaging software design and development.

Daxsonics values the diversity of our team and we are currently seeking qualified applicants from all intersectional backgrounds, with preference to those in equity-seeking groups.

Work Environment

Daxsonics believes in employee empowerment. Our team is self directed and personally accountable for our actions. We are highly motivated, work well together, and look at each challenge as an opportunity to strengthen our team. The expectation of Daxsonics employees is to meet targets, utilize the expertise of the team, and adhere to project schedules.

About You

In the Quality Lead role, you will conduct work to maintain Daxsonics’ Quality Management System in compliance with ISO 13485 and lead the team to consistently meet high standards of quality and conformance to defined processes.

Responsibilities include, but not limited to:

  • Ensure Daxsonics is compliant with international and regulatory standards as required for our internal Quality objectives, including:

o    Compile, Review, and Update, Standard Operating Procedures,

o    Organize training and ensure it is conducted,

o    Audit in-place procedures to ensure conformance,

o    Process Issues, and delegate corrective and preventative actions where appropriate

  • Encourage, foster, and maintain the culture of Quality within our organization.

  • Maintain the organization Quality Plan and establish Quality Objectives as required.

  • Work toward ensuring regulatory requirements for MDR and MDSAP are met.

  • Define quality targets, KPIs, performance objectives, etc.

  • Communicate and collaborate with other departments to ensure company goals and strategies are met.

  • Liaise with notified bodies to manage certification, as needed.

  • Drive development and/or modification of the QMS to ensure optimum state of QMS for current and future business needs.

  • Partners with the operations team to develop and maintain a robust internal and external supply chain.

  • Manage document and change control.

  • Ensure training has been implemented and documented for the team.

  • Knowledge of applicable medical devices safety standards (IEC/UL/ES 60601-1) and regulatory requirements and be capable of identifying those that are applicable for each unique project.

  • Work with client requirements for QMS, documentation, and support.

  • Work with customer and engineering teams to develop robust verification test strategies to ensure product safety and reliability. 

  • Develop process validation programs for new product development.

  • Participate in and potentially lead product Risk Analysis meetings and document the results as specified in ISO 14971.

Requirements

  • Bachelor’s in Science or Engineering (or equivalent discipline)

  • Multi-year experience in Quality with ISO 13485 and development of Medical Devices

  • Experience developing procedures (SOPs)

  • Experience in Quality Auditing

  • Knowledge of risk management and ISO 14971.

  • Demonstrated knowledge of CAPA, and corrective action processes.

  • Exceptional written and oral communication skills

  • Proficiency with MS Excel, MS PowerPoint, and other management software tools.  Experience with MS Project Online preferred.

Assets

  • Experience with electronic based QMS

  • Experience in taking a medical device through regulatory approval (FDA, MDR, MDSAP)

  • Highly developed coaching, mentoring and communication skills

  • Ability to present to, influence and build trusting relationships with executives.

  • Excellent interpersonal and communication skills, including technical writing skill.

  • Project management experience.

  • People management experience.