Microbix Biosystems is a fast growing biotechnology company based in Mississauga.
Founded in 1988 as a producer of infectious disease antigens, primarily for the diagnostics market, Microbix invests in the virology business to build capacity and develop new products to address emerging market opportunities, while enhancing manufacturing and laboratory capabilities and technologies.
Our emerging products take aim at large market opportunities. With Microbix' core competencies in the Diagnostics business, including cell culture, molecular biology, and GMP quality system, these new products build on Microbix' strength.
We are currently hiring for the following positions:
Microbix is seeking an experienced QA professional who is committed to ensuring completeness and accuracy in Quality Management System (QMS) processes and documentation. Reporting to the Director of QA and Compliance, a QA Manager will support various activities related to the upkeep of our ISO 9001 and 13485 QMS processes and will support existing products and new product introductions by providing and applying Quality Assurance expertise.
Assist the Director of Quality Assurance and Compliance with the maintenance and implementation of QMS processes:
• Ensure the design control activities are performed in compliance with company procedures and applicable ISO standards. Support new product introductions from a quality perspective. Review and approve documentation associated with the introduction or transfer of a new product from development to routine manufacturing
• Oversee risk management processes as applicable to new and existing products. Manage risk management file for and medical devices
• Provide QMS training and ensure annual refresher training for all employees engaged in routine operations
• Support and enhance performance by analyzing and assessing quality control and quality assurance data by identifying patterns and areas for improvements based on QA data over time and utilizes these reports to improve processes and performance
• Development of a formal reporting system to communicate and track results of identified patterns and trends such as dashboards and other metrics
• Assess customer requirements and commitments by reviewing quality agreements or other contracts and ensuring customer requirements are included in the company QMS
• Oversee supplier management program. Ensure that supplier qualification and performance evaluation is according to their criticality assessment and associated risks
• Perform other duties as assigned by the Director of Quality Assurance and Compliance
• Thorough knowledge of and the practical application of ISO 13485:2016, ISO 14971:2012 and FDA 21 CFR Part 820
• Ability to multi-task with ability to be organized. Strong time management skills and attention to detail
• Ability to work in a fast-paced environment with shifting changes in prioritization based on regulatory and business needs
• Good Working knowledge of risk management methods, techniques and analysis
• Strong interpersonal and communication skills. Excellent written and oral communication skills
• Proficient at supporting effective interactions between team members and among cross-functional teams.
• Proficient experience with MS Office suite (Word, Excel, Outlook)
• 5-10 years of experience in Quality Assurance management role in the medical device or pharmaceutical industries with a record of increasing responsibilities.
• Bachelor’s degree in Science, or related field
• Please submit your resume and cover letter at firstname.lastname@example.org