Quality Assurance Specialist

Overview

Perimeter Medical Imaging AI is a medical technology company driven to transform cancer surgery with its ultra-high resolution imaging technology to achieve our mission of advancing the standard of care, improving patient outcomes, and reducing healthcare costs. Our ultra-high-resolution, real-time, advanced imaging tools address areas of high unmet medical need.

With headquarters in Toronto, Canada and U.S. headquarters in Dallas, Texas, Perimeter Medical Imaging (TSXV:PINK)(FSE:4PC) has launched the next generation of imaging technology that allow surgeons to visualize microscopic tissue structures with unparalleled clarity in the operating room.

Job Description

As a Quality Assurance Specialist, your primary responsibility will be to support all aspects of and to ensure the effectiveness and conformity of the Company’s Quality Management System to the standards for our industry and relevant markets. The person selected for this role will proactively oversee Perimeter’s Arena eQMS, coordinate employee SOP training, ensure CAPA and NCR effectiveness, manage and approve suppliers, and conduct rigorous internal and supplier audits. The QA Specialist will have cross-functional, collaborative responsibility to ensure that our processes, procedures, and products meet the highest applicable standards for a medical device company.

Major Responsibilities

• Review and update Standard Operating Procedures for continuous improvement, effectiveness, and organizational compliance with applicable Quality Management System (QMS) requirements
• Support Perimeter’s Complaint Handling process, to include facilitating cross functional review, project management of investigation activities and other open actions, review and closure of complaint records, and evaluating trends within the complaint data
• Oversee Document Control activities to include setting up and routing change orders, reviewing documents and approvals, and project management of change implementation activities
• Ensure proper assignment and timely completion of employee training and appropriate archival of training records
• Maintain and update the Approved Suppliers List to include responsibility for validating suppliers
• Prioritize, schedule, oversee, and/or conduct supplier audits
• Support purchasing controls and verification of purchased products
• Coordinate and support timely investigations and dispositions for non-conformances
• Support the Corrective and Preventive Action (CAPA) process, to include identification of root causes, implementation of corrective actions, and conducting effectiveness checks
• Support development and approval of design and manufacturing documentation and records to include design verification and validation protocols/reports, equipment qualification protocols/reports, and DHR’s
• Review and provide feedback on manufacturing outputs and records to ensure compliance with the Quality Management System
• Conduct internal audits of Perimeter’s QMS
• Support certification/regulatory audits of Perimeter’s QMS
• Support verification and validation and relevant records of QMS tools
• Support calibration and recording of all test equipment and tools
• Assist other members Quality Assurance and the broader, cross-functional team in sustaining the effectiveness of the Quality Management System
• Other tasks and responsibilities as assigned

Essential Qualifications

• 5-7 years experience in a QA role in medical device industry
• Undergraduate degree in science is required; undergraduate degree in Computer Science, Electrical Engineering, Bioengineering, System Engineering, or Quality Engineering is preferred
• Understanding of Quality System Regulations and Standards (mature knowledge of 21 CFR Part 820, CMDR, and ISO 13485:2016 are required; (EU) 2017/745 is preferred)
• Understanding of ISO 14971 requirements
• Medical Device Complaint Handling experience is required; MDR and Vigilance reporting experience is preferred
• Experience implementing Supplier Quality Controls to include interfacing with suppliers, quality issue resolution, and monitoring supplier performance indicators
• Demonstrates knowledge of project management techniques to ensure predictability of complex cross-functional projects
• Ability to demonstrate technical expertise and communicate with internal and external customers and executive management
• Ability to monitor and report Key Performance Indicators (KPIs) of QMS processes
• Must be deadline-oriented and detail-oriented, an effective communicator, and able to work within a team environment
• Must be a self-starter and able to work independently under limited supervision while remaining highly productive with output of top-quality work product
• Must have excellent verbal and written communication skills
• Must be comfortable working in a remote/hybrid environment

Desired Skill Sets

• Previous experience working in a small company environment
• Demonstrable critical thinking, analytical and problem-solving ability
• Experience with the ICH Guideline for Good Clinical Practice
• Experience with software validation execution and documentation
• Understanding of IEC 62304, IEC 60601 requirements
• Familiarity with JIRA, JAMA, DocuSign, Arena, MS Office, Google Workspace

Certificates, Licenses, Registrations

• ASQ, CSQE or CQE preferred
• Internal auditor certification preferred

The above listing represents the general duties considered essential functions of the job and is not to be considered a detailed description of all the work requirements that may be inherent in the position.

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To apply for this role, please email us your resume and (optional) cover letter with “Quality Assurance Specialist” in the subject line to: [email protected]

Perimeter Medical Imaging AI is an equal opportunity employer and supports workforce diversity. Perimeter welcomes and encourages applications from people with disabilities. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.