Our mission is to Profoundly change the standard of care by creating a tomorrow where clinicians can confidently ablate tissue with precision; a tomorrow where patients have access to safe and effective treatment options, so they can quickly return to their daily lives. Changing the standard of care is part of our fabric. We are a group of energetic, problem-solvers focused on innovation, and looking to change the world. We are changing the paradigm for treating diseases such as prostate cancer by using real-time MR Imaging, thermal ultrasound and close-loop temperature feedback control, to gently ablate the diseased tissue with minimal side effects.If you share our values and want to work in a collaborative results focused culture and want to make a Profound impact in healthcare and your career, here is your chance.General AccountabilityWe are seeking a Quality Manager, Production who will be responsible for establishing and maintaining quality management systems to ensure products and process meet applicable regulations, requirements and specifications.Accountability includes the maintenance and improvement of the Quality Management System activities through Objectives & key results. This covers operations such as receiving/incoming, manufacturing, shipping, distribution and reverse logistics.This role plays a critical role in product safety, compliance, and batch/device release, working closely with QA, Manufacturing, R&D, and Regulatory Affairs.This role will lead inspection, testing, and release activities, ensuring compliance with MDSAP, ISO 13485, FDA QMSR (21 CFR Part 820), IEC standards, and applicable regulatory requirements.Duties and ResponsibilitiesResponsible for incoming, in-process, and final inspections to ensure product release is as per Medical Device File / Design Master File.Support quality activities for products in production, in house and outsources.Lead all incoming, in-process,



and final inspection/testing activitiesEnsure Device History Record (DHR) / Batch Record completeness, accuracy, and compliance before releaseOversee product release decisions (accept/reject) in accordance with specifications and regulatory requirementsManage inspection plans, sampling strategies, and acceptance criteria (e.G., ANSI/ASQ Z1.4 and Z1.9)Ensure QC processes comply with: 1. ISO 13485:2016 2. FDA 21 CFR Part 820 / QMSR 3. EU MDR (if applicable) 4. Relevant standards (e.G., IEC 60601, ISO 14971)Support internal, customer, and regulatory audits and inspectionsMaintain inspection and test records in compliance with data integrity (ALCOA+) principlesApprove and maintain: 1. Inspection procedures and test methods 2. Test method validation/verification (IQ/OQ/PQ where applicable)Ensure appropriate use of: 1. Functional testing 2. Electrical safety testing (e.G., IEC 60601) 3. Software verification checks 4. Oversee non-destructive and destructive testing protocolsEnsure incoming material inspection aligns with supplier quality agreementsCollaborate with Manufacturing Engineers/ Purchasing on Supplier performance issues and incoming defects / SCARsDefine and optimize receiving inspection strategies (including skip lot, risk-based approaches)Manage nonconforming product identification, segregation, and disposition, and recallsParticipate in Root cause investigations (RCA)



and CAPA activitiesEnsure proper documentation of rework/repair in compliance with regulatory expectationsEvaluate impact of nonconformances on product safety and regulatory reportingEnsure all inspection and test equipment are Calibrated and maintained and traceable to national/international standardsOther duties as assigned.Education & CertificationsA minimum of a bachelor's degree in science or engineering field.ASQ Certification in Quality management, Lean Six Sigma, Auditor or P.Eng.Key AttributesMinimum 7-10 years medical device experience; or equivalent combination of education and experience.Solid knowledge of device regulations and its applications such as FDA QSR, International Standards i.E, MDSAP, ISO 13485, ISO 14971; EU Medical Device Regulation (MDR), and Canadian Medical Device Regulations (CMDR).Language Skills: Ability to read, analyze and interpret common business documents. Ability to respond to common inquiries or complaints from customers, members of the business community.Strongcommunication,problem- solving, andorganizationalskills; AbilitytoworkindependentlyandinateamData analytics capability using statistical techniques and Power BI tools to make statistical inference.Excellent knowledge of Microsoft Office applications such as Excel, Power point, Visio, Word, etc.We thank you for your interest in Profound Medical. Please note only candidates that are short-listed will be contacted.The expected annual salary range for this role is $110,000-$140,000 CAD. Actual compensation will be determined based on experience, qualifications, and job-related factors. This role may also be eligible for participation in the company's benefits programs, such as a group RRSP and medical benefits paid by the employer.We strive to promote diversity and equal opportunity in the workplace and encourage applications from all qualified individuals, including those with disabilities. If selected to participate in the recruitment, selection, and/or assessment process, please inform Human Resources of the nature of any accommodation(s) that you may require.

📌 Quality Manager, Production (Mississauga)
🏢 Profound Medical
📍 Mississauga