Quality Assurance & Systems Specialist

Role Description :

This is a unique opportunity to join an early-stage company to advance the development of a novel implantable medical device, ensuring its readiness for human use.

Fluid Biomed is an innovative medical device startup focused on developing a cutting-edge neurovascular stent to treat brain aneurysms and enhance patient outcomes worldwide.

We are seeking a highly flexible and motivated person for the role of Quality Assurance & Systems Specialist to join our talented team.

Reporting to the Senior Quality Engineer, the Quality Assurance & Systems Specialist will act as management representative in owning and administrating the elements of the Quality Management System (QMS), manages the internal and external audit programs, and oversees training, and change management programs.

The role will work within the Quality Department in a fast paced and dynamic environment where attention to detail, ability to multi-task, taking initiatives and collaborating cross-functionally are critical for success.

Key Responsibilities include :

• Own and maintain effective QMS processes and procedures in accordance with ISO 13485 standards.
• Acts as Management Representative in coordinating regulatory compliance activities / audits with external regulatory affair / auditing bodies to obtain and maintain necessary ISO certifications and approvals.
• Under ISO 13485 requirements, lead the internal audit program and conduct internal audits to assess QMS requirements and identify areas for improvements in closing any gaps.
• Conduct mock audits in preparing the team towards ISO certification / recertification / surveillance audits.
• Initiate, investigate, and resolve non-conformance reports (NCRs), by implementing corrective and preventive actions (CAPAs) to address root causes of quality system issues in a timely manner.
• Address audit findings and opportunities for improvements (OFIs) in a timely manner.
• Manage document control activities including revision controls, SOP / document review and approval, document retention and archiving, electronic and hardcopy filing, etc.
• Develop and maintain ISO / ASTM / ANSI standards database and conduct gap assessments on newer versions.
• Manage change control activities including change requests review and approval, impact and risk assessment, route documents for approvals, implement approved documents, and close change requests.
• Review and approve technical and non-technical documents in compliance with QMS requirements.
• Prepare and lead QMS Management Review meetings and present to the team and executives.
• Establish and maintain key performance indicators (KPIs) to monitor quality system effectiveness.
• Manage overall training program and maintain training KPI reports, matrix, files, and records for all staffs.
• Provide training and education to staffs on quality processes, SOPs, and regulations as required.
• Lead and support quality systems improvement project activities across the organization.
• Assist in product quality assurance activities, including quality inspection, as required.
• Other quality department support activities as required.

Education and Experience Requirements :

• Bachelor’s degree and minimum 2 years’ of Quality Assurance and / or Systems experience in an ISO 9001 / 13485 industry required.
• Understanding or knowledge of the ISO 13485 requirements required.
• Demonstrated experience with Quality Management System, and internal / external ISO audit activities required.
• Experience or knowledge with root cause analysis techniques required.
• Experience or knowledge with change management process, including impact and risk assessment, required.
• General understanding of the training process required.

Additional Skills :

• Certification as Internal Auditor preferred.
• Excellent documentation, attention to detail, communication (written & oral), and interpersonal relationship skills.
• Strong problem-solving, organizational, analytical, and critical thinking skills.
• Ability to navigate uncertainty / fluidity in role scope, priorities, and timelines.
• Ability to manage competing priorities in a fast-paced and dynamic environment.
• Proven expertise in usage of MS Office Suite

Role is on-site in Calgary, AB and candidates must be legally entitled to work full time in Canada.