22 Sep
|
Technimount E.M.S. Holding
|
Quebec City
22 Sep
Technimount E.M.S. Holding
Quebec City
The Quality and Manufacturing Methods Technician acts as the direct interface between the company’s quality management system and manufacturing operations. The role is responsible for translating quality, regulatory, and documentation requirements into robust, repeatable, compliant, and auditable manufacturing practices. The position plays a key role in closing quality system gaps and preparing the company for expansion into new markets, particularly by supporting requirements applicable to Europe and other strategic jurisdictions, including ISO 13485, QMSR, MDR, UK MDR, MDSAP, and ISO 9001. The position serves as a key link between Engineering, Quality, Operations, Purchasing, Production, and Regulatory Affairs to ensure that manufacturing practices, controlled documents, and quality records are aligned with quality system requirements and the company’s growth objectives. The go-to resource for: The robustness of manufacturing methods; Manufacturingdocumentation discipline; Operational quality in production; Controlled implementation of changes; Traceability and quality records; Practical preparation of the manufacturing facility for the requirements of more highly regulated markets. KEY RESPONSIBILITIES MANUFACTURING METHODS AND STANDARDIZATION Define, write, structure, and maintain work instructions, manufacturing procedures, visual standards, assembly sequences, and manufacturing methods. Translate design, quality, and compliance requirements into clear, applicable, and auditable instructions for operations. Support production lines in optimizing work methods, ergonomics, repeatability, and execution robustness. Participate in defining standard times, control points, critical sequences,
and production validation requirements. Support the industrialization of current products and transfers to manufacturing. Ensure strong consistency between bills of materials, drawings, work instructions, fixtures, and actual manufacturing practices. QUALITY SUPPORT FOR MANUFACTURING OPERATIONS Act as the on-site quality resource for manufacturing operations. Support the handling of production non-conformities, root cause analysis, and implementation of corrective and preventive actions. Participate in the management of discrepancies, deviations, concessions, NCRs, and quality events related to manufacturing. Support first-piece inspections, incoming inspections, in-process controls, and document-based product releases. Strengthen the rigor of DHRs, DMRs, batch records, traceability data, and evidence of compliance. Contribute to improving day-to-day quality discipline on the production floor and within supporting processes. QUALITY SYSTEM INTERFACE AND OPERATIONAL COMPLIANCE Act as the integration point between the quality management system and manufacturing operations. Deploy quality system requirements within operational processes in a structured, simple, and sustainable manner. Identify gaps between current manufacturing practices and the requirements of applicable standards and regulations. Actively contribute to closing gaps related to ISO 13485, QMSR, MDR, UK MDR, MDSAP, and ISO 9001. Support the creation, updating, and control of procedures, forms, records, and evidence mechanisms required by the quality management system. Ensure that operational activities are aligned with applicable documentation, traceability, and control requirements. TECHNICAL CHANGES, VALIDATION, AND
📌 Methods And Quality Technician (Quebec City)
🏢 Technimount E.M.S. Holding
📍 Quebec City