Methods and Quality Technician

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;
• Manufacturing documentation 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 new 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 TRANSFER

• Participate in the assessment and implementation of technical changes affecting production, quality, and documentation.
• Support the Control Board from a manufacturing and operational quality perspective.
• Assess the impact of changes on methods, instructions, training, traceability, validations, and compliance.
• Participate in process validations, assembly validations, tooling qualifications, and manufacturing readiness reviews.

SUPPLIER QUALITY AND INCOMING MATERIAL COMPLIANCE

• Support incoming quality activities and the implementation of appropriate controls for critical components.
• Participate in the assessment of supplier discrepancies, documentation of quality issues, and follow-up on required actions.
• Contribute to the qualification, monitoring, and maintenance of approved suppliers.
• Strengthen consistency between technical requirements, purchasing specifications, incoming inspection controls, and regulatory expectations.

DOCUMENTATION, TRAINING, AND AUDIT READINESS

• Prepare, structure, and maintain controlled documents required to support a compliant manufacturing environment.
• Ensure that work instructions and shop-floor practices are understood, deployed, trained, and followed.
• Participate in the preparation of internal, external, customer, and certification audits.
• Support the collection of objective evidence, demonstration of compliance, and closure of audit findings.
• Contribute to building a more disciplined, traceable, and credible manufacturing environment in the context of market expansion.

CONTINUOUS IMPROVEMENT AND OPERATIONAL ROBUSTNESS

• Identify quality and manufacturing-method issues that negatively impact manufacturing performance.
• Recommend and implement practical improvements to processes, tools, documents, and controls.
• Participate in improving process stability, first-pass quality, repeatability, and clarity of standards.
• Implement useful monitoring mechanisms to highlight gaps, trends, and action priorities.

• High level of rigor and a strong sense of structure.
• Excellent ability to translate regulatory requirements into practical execution.
• Influential leadership on the shop floor.
• Ability to enforce standards without unnecessary bureaucracy.
• Analytical mindset, sound judgment, and solution-oriented approach.
• Strong ability to work cross-functionally with Engineering, Quality, Production, Purchasing, PMO, and Regulatory Affairs.
• Clear, direct, and credible communication.
• Autonomy, strong prioritization skills, and execution discipline.
• Strong desire to build, structure, and mature a function that is still being developed.