ZEISS Vision Looking for Quality Assurance / Process Excellence Specialist at Toronto, Ontario, Canada Full Time

Job description

What we’re looking for:

• Please note that this is a 6 month contract position with the organization*

We are seeking a dynamic and driven QA/Process Excellence Specialist to join our team at Carl Zeiss Canada Ltd. This role will be focused on enhancing our operational efficiency and compliance across various departments including Customer Care, Service, and Finance, all in support of our ISO 9001 quality management system. The ideal candidate will possess two to five years’ experience in a Quality Assurance (QA) position with a strong background in process optimization and a keen eye for detail. Medical device and/or regulatory affairs experience will be an asset.

Primary Duties and Responsibilities:

• Collaborate closely with cross-functional teams to identify process gaps, inefficiencies, and opportunities for improvement.
• Lead the development, documentation, and implementation of standardized operating procedures (SOPs) to streamline operations and ensure compliance with industry regulations.
• Work closely with the QA/RA Manager to align process improvements with established quality and regulatory standards, with a focus on continuous improvement.
• Conduct internal audits of existing processes using established SOPs and relevant regulations to ensure compliance and uncover enhancement opportunities.
• Employ process analysis techniques like FMEA to identify and mitigate potential risks comprehensively.
• Leverage QMS expertise to meticulously document processes and ensure alignment with quality standards.
• Implement data-driven methods for continuous process monitoring, delivering periodic management reports on performance
• Collaborate with teams to identify and implement best practices, fostering a culture of operational excellence and continuous improvement.
• Leverage your proficiency in tools such as MS Visio, SharePoint, and Teams to visuallyrepresent processes, facilitate communication, and enhance collaboration.

Experience and Education Requirements:

• Bachelor’s degree in Business Administration, Engineering or experience in a relevant field
• 2-5 years of experience in quality assurance / process improvement, ideally, but not necessarily within the medical device industry.
• Displays expertise in articulating procedures through well-crafted written content.
• Strong understanding of medical device QA/RA principles and regulations is a significant bonus.
• Experience working with high-regulated industries, such as medical devices, pharmaceuticals, or healthcare, is highly advantageous.
• Proficiency in Quality Management Systems (QMS) and process documentation is essential.
• Familiarity with Process Failure Mode and Effects Analysis (FMEA) methodologies is preferred.
• Expertise in utilizing tools like MS Visio, SharePoint, and Teams for process mapping and collaboration.

Working Conditions and Special Demands:

• Onsite in our North York office, Monday to Friday 8:30 am to 5:00 pm
• Eligible for future hybrid Work From Home (WFH) program