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Primarily focused on on-the-floor Quality Operations, the SME is responsible for enhancing the team&#39;s understanding of Cell and Gene Therapy quality requirements.</p>\n<p>The individual in this role must possess the ability to work independently, demonstrating excellent judgment and the capability to effectively engage with a diverse range of key stakeholders.</p>\n<p>Responsibilities:</p>\n<ul>\n<li>Fully own the Quality Operational tasks required to ensure compliant and safe execution of CGT operational activities in the CGT MOD facility.</li>\n<li>Oversee quality assurance processes for CGT products from development to commercial launch.</li>\n<li>Engage with cross-functional teams to ensure compliance with Global Processes and Regulatory standards.</li>\n<li>Manage risks associated with CGT product development and manufacturing, including finding risk-based and phase-appropriate solutions when issues arise.</li>\n<li>Foster a culture of open communication and collaboration among team members and stakeholders, with an aptitude to being able to have tough conversations when Quality decisions may not be favored across stakeholder groups.</li>\n<li>Provide coaching and mentorship to team members, promoting their professional growth and ensuring alignment to the Quality decisions made.</li>\n<li>Develop and implement strategies to improve quality assurance practices.</li>\n</ul>\n<p>Quality Assurance Oversight:</p>\n<ul>\n<li>Ensure compliance with regulatory requirements (GxP, ATMP) and internal quality standards throughout the product lifecycle.</li>\n<li>Act as a quality advocate between development, manufacturing, supply chain, and regulatory affairs.</li>\n<li>Provide risk-based solutions to issues that arise to ensure compliance to phase-appropriate Quality requirements, while also ensuring the flexibility to continue with process knowledge and development.</li>\n<li>Implement advanced risk management strategies, including conducting investigations (e.g., FMEA) and managing risk profiles associated with CGT products.</li>\n<li>Identify and mitigate potential risks related to quality assurance processes.</li>\n<li>Implement global CGT program elements into local procedures to ensure compliance to CGT program expectations.</li>\n<li>Analyze past performance to prevent recurrence of issues and improve future outcomes.</li>\n<li>Promote a culture of continuous learning and improvement within the quality assurance team.</li>\n<li>Engage directly in daily quality assurance activities and provide hands-on support to team members as needed.</li>\n<li>Maintain a practical mindset when addressing unforeseen problems and developing solutions.</li>\n</ul>\n<p>Regulatory Knowledge and Support:</p>\n<ul>\n<li>Ensure all documentation and processes are aligned with regulatory standards and best practices.</li>\n<li>Collaborate with Regulatory stakeholders to support the Regulatory filing and documentation needs.</li>\n</ul>\n<p>Communication 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practical solutions.</li>\n<li>Project Management Skills: Strong project management capabilities to handle both tactical and strategic elements of the role.</li>\n<li>Flexibility and Agility: The ability to adapt to changing environments and pivot strategies as necessary.</li>\n</ul>\n<p>Preferred Qualifications:</p>\n<ul>\n<li>Degree in Life Sciences, Engineering, or a related field is preferred.</li>\n<li>Advanced degrees (Master&#39;s or PhD).</li>\n<li>Proven track record in Quality Assurance specifically within Cell and Gene Therapy (CGT) or Advanced Therapy Medicinal Products (ATMP).</li>\n<li>Experience with both late-stage development and marketed CGT products.</li>\n<li>Strong background in Quality Management Systems (QMS) and experience with quality audits.</li>\n<li>Knowledge of critical quality attributes and process parameters relevant to CGT products.</li>\n<li>Experience with advanced risk management techniques, including FMEA (Failure Mode and Effects 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Continuous Improvement Engineer</strong></p>\n<p>Apply</p>\n<p>locationsConcord, Ontario</p>\n<p>time typeFull time</p>\n<p>posted onPosted 3 Days Ago</p>\n<p>job requisition idJR102774</p>\n<p><strong>Key Responsibilities and Authorities:</strong></p>\n<ul>\n<li>Monitor and analyse performance of assigned work centres; maintain and present monthly open issues, and lead data-driven continuous improvement initiatives for new and existing equipment.</li>\n</ul>\n<ul>\n<li>Support Toolroom and Maintenance by providing technical guidance, process insights, and updated documentation/drawings for equipment upgrades, troubleshooting, and modifications.</li>\n</ul>\n<ul>\n<li>Specify, requisition, and oversee the development, delivery, and integration of new equipment in accordance with internal tooling, machine, and programming specifications.</li>\n</ul>\n<ul>\n<li>Collaborate with internal stakeholders to ensure equipment and process solutions meet financial, spatial, and production layout requirements.</li>\n</ul>\n<ul>\n<li>Travel locally and internationally as required for on-site meetings, supplier reviews, and equipment acceptance trials.</li>\n</ul>\n<ul>\n<li>Capture photographs and videos within the facility for internal documentation and external communications related to job duties, ensuring proper usage compliance.</li>\n</ul>\n<ul>\n<li>Participate in quote meetings and prepare detailed internal costed equipment quotes; review with management and defend associated costs.</li>\n</ul>\n<ul>\n<li>Issue detailed RFQs to vendors, clearly communicating technical specifications and process requirements; coordinate with Packaging Engineering for packaging needs.</li>\n</ul>\n<ul>\n<li>Review vendor quotations to ensure compliance with RFQ specifications; request clarifications and challenge costs where necessary to optimise value.</li>\n</ul>\n<ul>\n<li>Lead internal and external open issues meetings, document and distribute minutes, assign follow-up tasks, and track closure across departments.</li>\n</ul>\n<ul>\n<li>Represent the department during customer visits and production runs, maintaining a high level of professionalism and understanding of audience needs.</li>\n</ul>\n<ul>\n<li>Develop capital approval packages and manage related documentation, purchase orders, invoice tracking, and alignment with program budgets.</li>\n</ul>\n<ul>\n<li>Support development and documentation of in-line plastics processes such as vibratory welding and injection/co-molding where applicable.</li>\n</ul>\n<ul>\n<li>Ensure completion and documentation of PHSR, ergonomic, and environmental assessments for all new equipment or major changes.</li>\n</ul>\n<ul>\n<li>Research and assess new vendors for equipment, tooling, and materials handling technologies; 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The total cash compensation range for this position is expected to be:</p>\n<p>$57,658.00 - $107,000.00</p>\n<p>_To learn more about Multimatic, check out our youtube channel - https://www.youtube.com/watch?v=psOjJIh3t90_</p>\n<p>_If you are interested in this position, apply by sending us your cover letter and resume._</p>\n<p>_We thank all interested candidates in advance; however, only individuals selected for interviews will be contacted._</p>\n<p>_As part of our commitment to ensuring our employment practices are fair, accessible, and inclusive of persons with disabilities, recruitment-related accommodations for disabilities, are available upon request throughout the recruitment and assessment process for applicants with disabilities._</p>\n<p style=\"margin-top:24px;font-size:13px;color:#666;\">XML job scraping automation by <a href=\"https://yubhub.co\">YubHub</a></p>","url":"https://yubhub.co/jobs/job_1f6dad6e-ef6","directApply":true,"hiringOrganization":{"@type":"Organization","name":"Multimatic","sameAs":"https://multimatic.wd10.myworkdayjobs.com","logo":"https://logos.yubhub.co/multimatic.com.png"},"x-apply-url":"https://multimatic.wd10.myworkdayjobs.com/en-US/MMEC/job/Concord-Ontario/Process---Continuous-Improvement-Engineer_JR102774-4","x-work-arrangement":"onsite","x-experience-level":"mid","x-job-type":"full-time","x-salary-range":"$57,658.00 - $107,000.00","x-skills-required":["IATF 16949","ISO 14001","WHMIS","OHSA","Design for Manufacturing (DFM)","Kaizen","Continuous Improvement","Process Improvement","Equipment Development","Vendor Qualification","Technical Documentation","Engineering Materials","Quality and Safety Requirements","Packaging Cost Development","Time Studies","Capability Assessments","PFMEA","Process Documentation","Operator Instructions","Setup/Changeover Sheets","Process Flow Diagrams","Safety/Lockout Procedures","Process Parameters","Capital Approval Packages","Purchase Orders","Invoice Tracking","Program Budgets","Equipment Training","Maintenance","Toolroom","Production","Materials","Warehouse","Quality","AQP","Test Lab","ECNs","DMNs","Launch Open Issues","Quality Open Issues","GP-12/Containment","Root Cause Resolution","Gemba Walks","TPM","JHSC","Design Open Issues","Prototype Builds","Milestone Reviews","Process Integration"],"x-skills-preferred":[],"datePosted":"2026-03-08T18:48:43.967Z","jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Concord, Ontario"}},"employmentType":"FULL_TIME","occupationalCategory":"Engineering","industry":"Automotive","skills":"IATF 16949, ISO 14001, WHMIS, OHSA, Design for Manufacturing (DFM), Kaizen, Continuous Improvement, Process Improvement, Equipment Development, Vendor Qualification, Technical Documentation, Engineering Materials, Quality and Safety Requirements, Packaging Cost Development, Time Studies, Capability Assessments, PFMEA, Process Documentation, Operator Instructions, Setup/Changeover Sheets, Process Flow Diagrams, Safety/Lockout Procedures, Process Parameters, Capital Approval Packages, Purchase Orders, Invoice Tracking, Program Budgets, Equipment Training, Maintenance, Toolroom, Production, Materials, Warehouse, Quality, AQP, Test Lab, ECNs, DMNs, Launch Open Issues, Quality Open Issues, GP-12/Containment, Root Cause Resolution, Gemba Walks, TPM, JHSC, Design Open Issues, Prototype Builds, Milestone Reviews, Process Integration","baseSalary":{"@type":"MonetaryAmount","currency":"USD","value":{"@type":"QuantitativeValue","minValue":57658,"maxValue":107000,"unitText":"YEAR"}}}]}