QA Manager

2 weeks ago

Toronto, Canada VoxNeuro Full time

**Job Title**: QA Manager

**Department**: Quality Assurance

**Reports to**: Senior Manager, Clinical Operations

Summary of Position
The Quality Assurance Manager is responsible for supporting VoxNeuro’s compliance activities, with a primary focus on the ISO 13485 Quality Management System. The QA/QC Manager will ensure that our compliance systems (i.e. Quality Management System (QMS), and Information Security Management System (ISMS)) are maintained, matured, and effectively socialized across the entire VoxNeuro team. This position will require communication and collaboration across all areas of the business.

About the Company
VoxNeuro develops reliable, accessible, leading-edge EEG-based brain performance software designed to support clinician expertise. The company’s FDA-registered software-as-a-medical-device (SaMD) harnesses the power of event-related potentials (ERPs) to objectively measure cognitive function by comparing an individual’s ERP data against a normative database in real time. VoxNeuro instantly generates an easy-to-interpret and patient-friendly report that delivers scores for three key cognitive domains: attention and concentration, information processing, and memory. These scores indicate whether an individual’s cognitive function is within a healthy range based on their demographic profile and can be used as a basis for treatment plans. VoxNeuro can also inform neurological practice over the long-term by improving applicability of treatments, and the repeatability of the assessment enables tracking of changes in cognitive health over time.
At VoxNeuro, our mission is to give everyone’s brain a voice. We are one team acting together in support of the larger mission, and we’re all equally invested. We honor humanity. We’re all different and that is a strength. We create space for greatness and prioritize transparency. We challenge ourselves to think big and small, long and short - right side up and upside down. Innovation is at our core, we’re inspired by achieving things that have never been done before.
VoxNeuro is currently headquartered in Toronto, Canada, and is building out a team in the US. We are currently structured as a combination of in-office and remote work, recommending 50% of time spent in office each week for team members within commuting distance.

Essential

**Responsibilities**:

- Lead the maturation, implementation, and maintenance of the entire ISO 13485 QMS (i.e. Quality System Procedures, Work Instructions, Forms etc.)
- Lead an internal audit program, conducting gap/non-conformance assessments across the company
- Lead VoxNeuro through surveillance and recertification audits performed by external agencies (i.e. Health Canada, ISO Registrar, FDA, etc.)
- Responsible for supporting the company in creating complete and accurate quality records
- Coordinating QMS and Information Security Audits with external agencies
- Coordinate critical QMS functions, such as Risk Management, Corrective and Preventative Actions, Post-Market Surveillance, Supplier Evaluations, among others
- Respond to any potential Quality Incidents / Investigations and bring quality issues to resolution
- Communicates to staff on Quality requirements and supports participation by staff in all aspects of the QMS
- Lead VoxNeuro compliance training programs, and monitor effectiveness of training
- Support the development, maintenance, and monitoring of the Information Security Management System (ISMS), its procedures (ISPs), and controls
- Coordinating and supporting Information Security Audits with external agencies
- Supports the Senior Manager, Clinical Operations as required with respect to regulatory efforts
- Regularly engage with third party stakeholders for RA/QA services
- Other duties as assigned

Qualifications Required for Position
- Education: Bachelor’s Degree, or equivalent
- Experience with QMS and ISMS Standards (i.e. ISO 13485, HIPAA/SOC2, ISO 27001 etc.)
- Experience with Medical Device Regulations, specifically: ISO 13485 (current issue), MDSAP, Health Canada, and FDA
- Experience leading internal and external audit programs
- Experience leading Risk Management programs (ISO 14791: 2017)
- Experience conducting creating and executing company-wide training programs
- Experience with process management
- Strong critical thinking and problem-solving skills
- Must be able to manage priorities and meet deadlines
- Ability to work independently as well as part of a team
- Must possess excellent communication skills and be self-motivated
- Strong attention to detail
- Proactive and able to continuously manage change efficiently and effectively
- Continuous learner with an analytical mind
- Legally registered to work in Canada or the United States
- Valid driver's license
- Valid passport
- No restrictions on travel throughout North America or Europe
- 2 Letters of Reference

Work Environment
VoxNeuro is currently headquartered in Toronto, Canada, and is building out

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