Quality Assurance Engineer

Job Description

<p><h3>Overview</h3><p>SciCan is a market leader in the manufacture and distribution of dental and medical equipment. SciCan\'s sterilization and disinfection equipment is sold in over 80 countries worldwide. SciCan is located in Toronto near the intersection of Highways 401 and 404 (Don Mills and York Mills). It is accessible by public transportation.</p><p>We currently have an opening for a Quality Assurance Engineer as part of our Quality Assurance Department. This position will be responsible for executing a range of quality assurance activities, including but not limited to; managing the calibration and maintenance program for tools and measuring equipment; coordinating and conducting final inspection procedures for finished products; monitoring and resolving open Temporary Deviation Notices (TDNs); and organizing training initiatives for newly onboarded personnel. This role plays a critical part in ensuring compliance with quality standards and supporting continuous improvement.</p><h3>Job Duties & Responsibilities</h3><ul><li>Review, update, and maintain quality documentation including procedures, manufacturing instructions, and forms.</li><li>Oversee the Calibration and Maintenance Program for all tools and measuring equipment.</li><li>Notify relevant departments of upcoming calibration deadlines.</li><li>Coordinate the shipment and receipt of equipment with external test and calibration facilities.</li><li>Organize and perform final inspection activities for finished products in collaboration with QA personnel, in accordance with the production schedule.</li><li>Assist in validating production processes to ensure compliance and efficiency.</li><li>Facilitate supplier onboarding and manage periodic evaluations and re-evaluations.</li><li>Collaborate with cross-functional teams to address product quality concerns and support related initiatives.</li><li>Prepare and analyze production quality reports; investigate root causes of failures and recommend corrective actions.</li><li>Develop and manage training programs for the Quality Assurance department.</li><li>Conduct in-process inspections of finished products as scheduled.</li><li>Monitor and resolve open Temporary Deviation Notices (TDNs).</li><li>Develop and maintain various Quality departmental KPIs</li><li>Investigate customer complaints and coordinate root cause analysis.</li><li>Perform internal audits of the Quality Management System and supplier audits as required.</li><li>Provide support and backup coverage for QA team members.</li><li>Support various Quality projects as required</li><li>Execute additional tasks as assigned by the Quality Assurance Manager to uphold the Quality Management System and departmental objectives.</li></ul><h3>Educational and Experience Requirements</h3><ul><li>Degree in Quality Engineering or Engineering Degree plus Quality Certificate</li><li>Minimum of 2 years related experience in a Medical Device manufacturing environment preferably with technology related products</li><li>Extensive familiarity with ISO 13485, preferably the 2016 version; MDSAP experience and application an asset; MDR experience is an asset</li><li>Internal auditing and risk management experience an asset</li><li>Strong communication skills both verbal and written</li><li>Ability to work in groups as well as independently with minimal supervision</li><li>Strong analytical and problem-solving skills are essential</li><li>Proven ability to deliver presentations and training, effectively and efficiently with clear communication skills and delivery</li></ul><h3>Additional Information</h3><p><b>We offer</b>: Competitive compensation, comprehensive Benefit & Pension program, continuing education reimbursement program, Fun & Positive team environment, a subsidized cafeteria, wellness programs, and free parking to name a few. You may learn more about SciCan business and products by visiting our website at <b>www.scican.com.</b></p><p>We thank all candidates for their interest in SciCan. Candidates that meet the above requirements will be contacted for an interview. No phone calls please.</p><p>By applying and submitting your resume to our job posting, candidate acknowledges and confirms that the submitted resume is true and that the candidate is able to provide evidence of academic achievement or other information as required.</p><p>SciCan strongly believes that diversity in the workplace is essential to our success. We are committed to providing equal opportunities regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, disability, gender identity and we are committed to accommodating applicants with disabilities throughout the hiring process, in accordance with the Accessibility for Ontarians with Disabilities Act (AODA). Accommodations are available upon request for candidates taking part in all aspects of the recruitment and selection process.</p></p>
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