Quality Systems Associate, Intermediate

4 weeks ago

Toronto, Canada Synaptive Medical Inc. Full time

About Us
Synaptive Medical is a Canadian medical device company, based in downtown Toronto, focused on supporting healthcare professionals and systems in patient diagnosis and treatment. Synaptive’s suite of products include MRI, surgical planning, navigation, and robotic visualization - all of which can be seamlessly combined or used independently in the operating room. The company has a number of opportunities for innovative people to join the team and share in the development of technologies to solve surgical and imaging challenges in patient care.

The Opportunity
We are seeking a Quality Systems Associate to join our Quality team. As the Quality System Associate you will provide daily support in maintaining and improving the QMS. This role is centered on ISO 13485 Quality Management System.
Working under general supervision, you may also develop, reconfigure, test, and deploy software-based quality tools used in the Quality Management System.

What You’ll Do
- Quality System Realization
- Assist in overseeing change management process, including administration of PLM software
- Manage complaint files, conduct risk assessments, escalating issues as appropriate
- Participate in internal audits and other periodic monitoring activities
- Participate in CAPA process
- Manage tool calibration program
- Quality System Improvement
- Identify and analyze risks to the QMS
- Interact with other departments to develop a compliant quality system using industry best practices as a foundation
- Write Standard Operating Procedures and work instructions
- Participates in improvement projects as required by direct supervisor
- The employee may perform other related duties as necessary to meet the ongoing needs of the organization.

What You’ll Need
- Undergraduate Degree
- Understanding of ISO 13485 or similar Quality System standards
- 1+ years of related experience

It’d Be Amazing If You Had
- Previous exposure to quality principles and tools in the medical devices industry
- Experience with using PFMEA methodology
- Basic understand of how medical devices are regulated
- Academic background in sciences, engineering, or mathematics
- Experience with data processing and statistical analysis
- Experience with JavaScript, software requirements, software test planning/execution
- ISO 13485 Internal Auditor Certification

About You
- Self-motivated and results oriented
- Commitment to work collaboratively with colleagues towards team objectives, in-line with guiding principles
- Enthusiasm towards learning new methodologies of working, which may involve shedding habits
- Communication of intent to support decision-making and team alignment
- Perceptiveness of emotional intelligence, and employment of active listening skills
- Resourcefulness to research topics or investigate issues without instructions
- Cooperation when new strategies, processes, tools, and business/regulatory requirements require adaptation
- Responsiveness to constructive feedback by striving for continuous improvement

COVID-19 Considerations

Diversity & Inclusivity
Synaptive is based out of one of the most diverse countries in the world. This includes differences related to race, ethnicity, national origin, gender, gender expression and presentation, sexual orientation, religion, age, ability and socioeconomic status. To us, diversity is one our strongest assets to our organization. We commit ourselves to promoting the recognition and appreciation of our diverse and rich culture. We believe that it is critical to our success to promote freedom of thought and opinion in a respectful environment. The decisions we make are rooted by respectfully considering each other’s thoughts and opinions and by working towards a greater common goal, saving lives.

Accommodation

How to Apply

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