Quality Assurance Specialist
As the Quality Assurance Specialist your main area of responsibility will be supporting Quality Management activities. Day to day duties will include developing and maintaining Quality System procedures that are in compliance with ISO 13485, FDA, MDD, and CMDR requirements, and assisting other team members with Quality processes
● Perform document and change control activities
● Update and maintain quality assurance procedures and activities required to ensure that the company’s processes and products are in compliance with applicable quality standards and requirements
● Support the transition of Perimeter's QMS from ISO 13485:2003 to ISO 13485:2016 and support all Quality System audits.
● Monitor quality assurance metrics; analyze and report trends to management. Make recommendations for improvement.
● Employ quality assurance methodologies in support of engineering, manufacturing and regulatory functions
● Monitor and follow-up with applicable stakeholders for investigation of non-conforming material, product complaints, customer feedback and CAPA activity completion, and review completed failure investigations for those activities.
● Assist in development of Quality Plans and Quality Agreements for critical suppliers and contract partners
● Assist with supplier audits (as necessary)
● As required, participate in different stages of design development, V&V testing and design control activities, ensuring quality assurance considerations and requirements met
● Assist in preparation for and conducting of regulatory agency inspections
● Develop and/or revise procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other production and process related documentation as required.
● Assists in ensuring quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility.
● Filing, EDMS validation and maintaining training records of employees as required
● Other tasks as assigned
● Post-graduate degree in Quality Management or equivalent
● 1- 3 years of related work experience in Office Administration activities, Documentation Controls, and/or data entry
● Minimum of 1 year experience working in a regulated industry
● Ability to communicate effectively in English (both written and oral)
● Fluent in computer skills and, at a minimum, the use of Microsoft Office Word, Microsoft Office Excel, Microsoft Office PowerPoint and Microsoft Office Project programs
Highly Desired Qualifications:
● Experience working in a small team or start-up environment
● Exceptional problem solving skills and ability to “think outside the box”
● Ability to work in a team and independently, as required.
● Self-motivated and self-directed
● Ability to handle and prioritize multiple tasks
● Highly detail oriented
How to Apply
Potential applicants – if interested in this position please submit your resume, along with a cover letter highlighting your suitability for this position and any questions to:
email@example.com or apply directly to our website at www.perimetermed.com
Please include in the subject line “Quality Assurance Specialist”.
All applications will be kept confidential. We thank all candidates for their interest but only candidates selected for an interview will be contacted.
Please NO recruiters.
At Perimeter Medical Imaging Inc. we value diversity and encourage applications from all qualified candidates including women, visible minorities, Aboriginal peoples, and persons 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.