Quality Systems Specialist (Maternity Leave Replacement)

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 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 procedures and work instructions. There are direct responsibilities for simplification projects, oversight and maintenance of records, including internal audit assist and CAPA specific tasks.   The ability to evaluate and manage risks, risk treatment planning, and monitoring 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          

• Lead and supports Quality System Improvement projects
• Interact with other departments to develop a compliant quality system using industry best practices as a foundation
• Assist in document management activities such as creating and updating procedures, process flow diagrams and work instructions
• 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
• Perform routine quality control tasks required in medical device development, manufacturing, and servicing
• Administrative oversight of tool calibration activities
• The employee may perform other related duties as necessary to meet the ongoing needs of the organization

Qualifications

• Undergraduate degree in engineering, project management or equivalent experience
• MDSAP ISO 13485:2016 Internal Auditor Training
• Minimum 5-year experience working in a medical device regulated industry

Beneficial

• Experience with configuration management of Product Lifecycle Management Systems (Fusion preferred)
• Previous Quality Assurance experience in the medical device industry
• Knowledge of 21 CFR 820, ISO13485:2016, MDSAP and ISO 14971
   

Interpersonal Skills

• Committed to work collaboratively as part of a team
• Willing to pivot and adapt to new strategies, processes, tools, and business/regulatory requirements
• Able to engage in active listening and to communicate clearly and effectively
• Receptive of constructive feedback and able to strive for continuous improvement
• Self-motivated and self-managing Special Requirements/Conditions
   

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

The Fine Print

The employee may perform other related duties as necessary to meet the ongoing needs of the organization.

Synaptive Medical is an equal opportunity employer and welcomes applications from all qualified individuals, including visible minorities, Indigenous People, and persons with disabilities.

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

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.