Compliance Specialist, II (12 month Fixed term)

Customer Care         ·        Toronto, ON, Canada      ·        Full time

• Location: Toronto, ON, Canada
• Req #: 652
  
• Posted On: Thursday, January 5, 2023

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 have an exciting and unique opportunity for a Compliance Specialist to oversee and improve the quality of the Customer Service team’s output at Synaptive Medical. Key responsibilities include the implementation and training of quality policies, ensuring accuracy of execution and completeness of records in accordance with Synaptive’s quality system. In addition, the Compliance Specialist will work with management to develop, implement, and maintain service and installation quality assurance processes.

This role is dedicated to facilitating and reviewing Customer Care quality, the improvement and training of our quality system, and the delivery of quality objectives. This high visibility position will interact with and rely upon resources and contributions from Engineering, QA, and many other departments within Synaptive.  

What You’ll Do          

• Review Customer Care requirements for the quality system and develop solutions for achieving those requirements through improved use and integration of the system
• Develop and post monthly metrics, feedback reports, KPI’s and dashboards
• Perform ongoing departmental gap analysis and work with functional managers to leverage opportunities for improvement and alignment
• Complete and maintain overarching departmental process mapping for departmental processes and work instructions
• Process and procedure development, review, and approval
• Proactively identify issues and potential trends requiring investigation by internal resources
• Implement tools to accurately track, measure and report on project activities and timelines
• Ensure proper handling and closure of all support related CAPAs including task tracking and root-cause analysis
• Assist with the training and support of the product life-cycle management system (PLM)
• Maintain a Customer Care quality assurance system that ensures compliance to ISO 13485 and FDA 21 CFR Part 820 Quality Systems Regulation
• Perform internal departmental audits and support external audits such as MDSAP
• Facilitate and support quality and regulatory in the investigation and resolution of complaints
• Review and approve service work orders in Service ERP relating to: repairs, installations, planned maintenance, updates, and de-installations.
• Follow up with Clinical Applications, Field Support, and Product Services for clarifications on Service documentation.
• Provide weekly updates on the status of Service Records.
• Review and approve all service quality compliance documentation including engineering change orders, non-conformances, training records, and documentation pertaining to service activities.
• Review and support the Global Field Support Manager on the maintenance of the Planned Maintenance schedule and work closely with the Field Service team for implementation
• Work closely with Product Services, Field Support, Engineering and System Test teams on product pre-release activities including review of upgrade procedures and documentation, development of Service Plan, update/develop Service PFMEA, documentation impact assessment and update, service training slides, continuity testing, and deployment validation
• Lead Service Activities during product recalls and end of life.
• Performs other compliance related tasks as assigned

What You’ll Need

• Bachelor’s degree in an engineering, science, or equivalent field
• At least five years of related work experience in a data-driven, regulated environment (e.g., automotive, medical device, pharmaceuticals, aerospace, nuclear)
• Experience with customer service and installation teams
• Experience in business process mapping (including planning, implementation, review, and improvement)
• Experience in troubleshooting and root cause analysis
• Experience working with application systems
• Valid driver’s license and passport

It’d Be Amazing If You Had

• Experience with PLM, CRM, ERP, and issue tracking software such as JIRA
• Knowledgeable of the following standards: IEC 60601, ISO 13485, ISO 14971

About You

• Self-motivated, self-managing, and goal oriented
• Ability to work in a highly technical, fast-paced environment
• Must be able to explain and generate detailed guidelines and procedures
• Ability to communicate clearly and effectively
• Ability to motivate others to achieve quality and regulatory compliance
• Strong presentation skills

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.

Other details

• Job Family: Customer Care
• Pay Type:  Hourly

Please click here to apply.