Quality and Regulatory Compliance Engineer (Machinery / OHS)

Vacation: 22 days + birthday

We are looking for a proactive and detail-oriented Quality Engineer to oversee the quality control of our production, international machinery certification, and Integrated Management Systems (ISO 9001, ISO 14001, ISO 45001). In this role, you will assume final responsibility for ensuring that all equipment shipped from our facilities meets international compliance standards, strictly respects safety regulations, and maintains our high standard of manufacturing excellence.

• Documentary control: review, validate, and approve manufacturing dossiers, instruction manuals, technical drawings, and bills of materials (BOM) before release to production.

• Traceability and Change Management: Trace components and sub-assemblies from design approval to final shipment. Manage Engineering Change Notifications/Requests (ECN/ECR) to ensure that production operates strictly based on updated technical documentation.

• Inspection and Audit Preparation: Oversee quality control points at all stages of production; lead and promote internal and external compliance audits.

• Shipment Supervision: Monitor production line flow and perform final quality validation (sign-off) to prevent delivery constraints without compromising quality.

2. Certification, Machinery Homologation, and Regulatory Compliance

• CE Marking and Directives: Lead full machinery certification in compliance with the EU Machinery Directive (and regional equivalents).

• Global Market Homologation: Manage international certification projects for equipment export, including Brazilian (NR-12/NR-13) and North American (ASME/UL) standards.

• Technical Process Management: Compile, structure, and maintain complete Technical Manufacturing Processes (TCF) for all machine lines.

• External Liaison: Act as the primary technical point of contact with notified bodies, testing laboratories, and regulatory inspection agencies.

• Risk Assessment: Perform safety risk assessments on machinery before shipment (e.g., ISO 12100) and implement mitigation strategies before Factory Acceptance Tests (FAT).

• System Maintenance: Maintain and continuously improve the QMS (Quality Management System) in compliance with ISO 9001 standards.

• Non-Conformities and Root Cause Analysis: Lead Non-Conformance Report (NCR) workflows and execute Corrective and Preventive Actions (CAPA) using structured problem-solving methodologies (8D, 5 Whys, FMEA, Ishikawa).

• Metrics and Reporting: Monitor key quality KPIs (first pass yield/FPY, scrap rate, and audit findings) and present monthly executive metric reports to management.

• Occupational Health and Safety (ISO 45001): Ensure the application of health and safety policies across all facilities to maintain full legal compliance. Promote a proactive safety culture through daily shop floor inspections, hazard identification, and enforcement of mandatory PPE use.

• Incident Management: Lead immediate investigations of accidents, near-misses (near-misses), and safety observations; design and enforce corrective and preventive measures.

• Environmental Management (ISO 14001): Oversee environmental operations on the shop floor, including hazardous waste handling, resource management, and emissions control.

• Assertive Decision-Making: Confidence in applying stop-work authority (stop-work authority) or in withholding non-conforming product batches under high-pressure scenarios, articulating clear engineering justifications to production managers.

• Resilience and Professional Integrity: Maintain uncompromising standards of safety and compliance, even under tight production deadlines.

• Systems Thinking: Strong analytical capacity - ability to associate how small production deviations impact equipment safety, legal liability, operational performance, and customer satisfaction.

Position: Quality and Regulatory Compliance Engineer (Machinery / OHS)

Location: Ronfe, Guimarães (with initial training in Vila Nova de Famalicão)