Quality Specialist

2 weeks ago

Toronto, Canada Fluid Biomed Inc. Full time

This is a unique opportunity to join a 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 Specialist to join our talented team. Reporting to the Quality Engineer, the Quality Specialist will act as management representative in administrating the elements of the Quality Management System (QMS), lead the quality inspection and supplier quality activities, manage overall inventory, training, and calibration programs, and support the Engineering and Operations team. 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
Manage company document control activities including revision controls, SOP/document review and approval, document retention and archiving, electronic and hardcopy filing, etc.
Maintain Technical documents (Engineering Specifications & Drawings) library
Complete receiving documentation for incoming parts, components, or equipment
Prepare and lead annual QMS Management Review meetings and present to the team and executives
Act as Management Representative in coordinating regulatory compliance activities/audits with external regulatory affair bodies to obtain and maintain necessary ISO certifications and approvals
Under ISO 13485 requirements, maintain and execute the internal audit process to assess compliance with QMS requirements and identify areas for improvements
Establish and maintain key performance indicators (KPIs) to monitor product quality and process effectiveness
Lead and improve product inspection activities, including the development of standard inspection reports, and communicating with internal and external stakeholders
Initiate, investigate, and resolve non-conformance reports (NCRs), by implementing corrective and preventive actions (CAPAs) to address root causes of product and process quality issues, and prevent recurrence in a timely manner
Own and maintain Approved Supplier List (ASL) including qualification, approval, development of quality agreements, and performance evaluation of suppliers in coordination with Engineering team
Assist in the procurement and installation of necessary quality and operational equipment by preparing request for quotes (RFQs), shipping documentation, technical qualification documentation, etc. as required
Maintain supplier quality documentation including Certificate of Analysis, inspection reports, etc.
Execute Non-Disclosure Agreements (NDAs) for external service providers, as required
Manage overall equipment calibration process including maintenance of calibration/maintenance reports, and coordinate ongoing equipment service or testing, in coordination with the Engineering team
Manage overall inventory control process including physical and electronic inventory of conforming/non-conforming product, delivery components, and supporting equipment
Manage overall training program and maintain training KPI reports, matrix, files, and records for all staff
Provide training and education to staff on quality processes, procedures, and regulations as required
Lead and support continuous improvement project activities across the organization
Support other Quality Department activities as required

Education and Experience Requirements:

Bachelor’s degree and a minimum of 2 years’ experience with QA/document control in industry required
Experience working in ISO 9001 or 13485 certified organization required
Demonstrated experience with Quality Management System, and audit activities required
Experience or knowledge with root cause analysis techniques required
General understanding of the training, calibration and inventory processes required
Demonstrated attention to detail and excellence in written communication

Additional Skills:

Experience as lead resource with document control software preferred
Certification as Internal Auditor preferred
Previous R&D/technical industry exposure, able to understand company technology at a practical level
Excellent documentation, communication, 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.

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