6000 - Quality Systems Specialist

About Us
Synaptive Medical is a Canadian medical device company, based in the Greater Toronto Area (Mississauga, Ontario), providing advanced precision imaging and intervention technology for improved diagnosis and treatment. Synaptive's suite of products include Magnetic Resonance Imaging (MRI) systems, surgical planning, navigation, and robotic visualization. These products can be seamlessly combined or used independently in the operating room to improve detection and treatment for oncology, stroke and neurogenerative patients. The company has a global footprint of high-profile customers operating 24-7 for the betterment of all patients.

The company has several opportunities for passionate and 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 Specialist to join our Quality Assurance department. Working under general supervision, this role is heavily involved in the creation, review and approval of Synaptive's QMS procedures and work instructions. This position is responsible for maintaining an ISO 13485, MDSAP and MDR compliant system. Other direct responsibilities include: analyzing complaints for reportability, continual improvement projects, oversight and maintenance of records, including internal audits and being an advocate for quality across the organization. This is an opportunity to evaluate and manage risks, risk treatment plan, and monitor the implementation of risk mitigations and to evaluate their effectiveness, all of which support the Synaptive Quality Management System.

This role will reside on the Quality System team, which has a mission to provide a compliant and effective Quality Management System (QMS) that helps Synaptive and its employees achieve their collective objectives.

What You'll Do

• Interact with other departments to develop and maintain a compliant quality system using industry best practices as a foundation
• Identify compliance gaps and develop plans to address those gaps
• Update, develop SOPs and ensure timely implementation of the SOPs in Fusion Electronic System
• Assist in document management activities such as creating and updating procedures, process flow diagrams and work instructions
• Lead and supports Quality System Improvement projects
• Oversee product quality complaint investigations, providing quality input and ensuring regulatory compliance.
• Oversee the review and approval process for Engineering Change Orders (ECOs), and Document Change Orders (DCOs), ensuring that all changes are appropriately managed and aligned with quality standards.
• Partner with HR in the management of the training matrix.
• Responsible for the administrative management and oversight of the Fusion Electronic System
• An active participant in the review of CAPA Tasks, including investigation, RCA, corrective and corrective action
• Responsible for identifying new QMS risks and risks mitigation of identified risks using Process Failure Modes and Effects Analysis
• Assist in the creation of internal audit plans and participate in internal/external QMS audits
• Identify risks and justify acceptable risks across the quality management system
• Update quality monthly KPIs and take appropriate action to address those KPIs with direct responsibility
• Perform routine quality control tasks required in medical device development, manufacturing, and servicing
• Perform other related duties as necessary to meet the ongoing needs of the organization

What You'll Need

• Bachelor's degree or equivalent experience
• Minimum 5-year experience working in a medical device regulated industry
• MDSAP ISO 13485:2016 Internal Auditor Training

It'd Be Amazing If You Had

• Experience using software platform, such as Fusion, Trackwise or MasterControl
• Previous Quality Assurance experience in the medical device or similar industry
• Knowledge of 21 CFR 820, ISO13485:2016, MDSAP, MDR and ISO 14971

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

COVID-19 Considerations

Synaptive has a special duty to take a leadership role in protecting the health and wellbeing of its employees and the public. The COVID-19 vaccines are an important public health measure for mitigating the spread of COVID-19 in the workplace and society. As a condition of employment, the successful candidate will be asked to provide proof of vaccination or a reason protected by legislation why they cannot be vaccinated against COVID-19.

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

Synaptive Medical is an equal opportunity employer and welcomes applications from all qualified individuals, including visible minorities, Indigenous People, and persons with disabilities. We welcome and encourage applications from people with disabilities. If as a qualified job applicant, you request accommodation, Synaptive will consult with you to provide reasonable accommodations according to your specific needs. If you wish to make a request, you will be provided an opportunity if your application is selected to proceed in our hiring process.

How to Apply

Unless otherwise stated, applications will only be considered from candidates eligible to work in Canada, or the country in which they're applying to, without sponsorship.

If you are interested in this position and can demonstrate that you meet or exceed the requirements defined in the job description, please include
#GOBRAIN
in the top right corner of your resume and then complete your online application by clicking "Apply Now" and following the prompts.

The successful candidate to this role will be asked to complete background checks, which may include criminal, credit, employment and/or educational checks. All offers of employment are conditional on the receipt of satisfactory results of any applicable background check.

We would like to thank everyone who submits an application. Due to the volume that we receive, only those candidates selected for interviews will be contacted.