Quality Engineer - Production

Company: ANEUVO

About the role:

ANEUVO is seeking a hands-on Quality Engineer (Production) to own in-line quality execution on our manufacturing floor within an ISO 13485 quality system. You will perform receiving inspection (RI), in-process quality control (QC), and outgoing/finished-goods inspections, ensuring products meet specifications and ship on time. This role emphasizes executing established procedures, test methods, and control plans, while helping drive swift containment, root cause verification, and corrective actions in collaboration with production, test, and supply chain.

Key responsibilities

• Receiving Inspection (RI)
• Execute incoming inspections per drawings/specs, AQL/sampling plans (ANSI/ASQ Z1.4), and work instructions.
• Verify supplier Certificates of Conformance (CoC), material certifications, and traceability per ISO 13485 and ANEUVO requirements.
• Use calibrated measurement tools (e.g., calipers, micrometers, gauges) and basic metrology.
• Log results, quarantine nonconforming material, and initiate SCARs/NCs in the QMS.
• In-Process QC and Test Execution
• Perform in-process inspections at defined checkpoints; verify CTQs and specification limits.
• Execute established electrical/mechanical/functional tests; record results with full traceability to lots/serials, per ISO 13485 documentation controls.
• Support RI- and production-related test setups, fixtures, and equipment checks; ensure calibration status is current.
• Monitor adherence to work instructions, control plans, and device master records (DMR); escalate deviations immediately.
• Outgoing/Final Inspection
• Conduct final inspection and verification testing on finished goods; review DHR/Device History Records (travelers) for completeness and compliance.
• Validate labeling, UDI/serialization (if applicable), packaging, and shipping documentation accuracy.
• Release or hold product based on acceptance criteria; lead immediate containment for escapes.
• Nonconformance and Containment
• Identify, document, and disposition nonconformances in the eQMS per ISO 13485 procedures.
• Support root cause verification and corrective actions; contribute to CAPA at the production level.
• Communicate defects and trends to production, test, and supply chain; drive quick-turn containment.
• Documentation and Traceability
• Maintain accurate inspection and test records, DHRs, logs, and electronic data entries aligned to ISO 13485 record-keeping requirements.
• Ensure component and lot traceability across RI, in-process, and final stages.
• Propose updates to work instructions and checklists when gaps or ambiguities are found.
• Continuous Quality Support and Audit Readiness
• Track yields, defect Pareto, and basic SPC checks; flag drifts and abnormal trends.
• Participate in daily stand-ups and line walks; champion right-first-time and safe-by-default behavior.
• Support readiness for internal audits, customer audits, and regulatory inspections.

Qualifications

• 3+ years in production quality, in-process QC, or final inspection within manufacturing; medical devices or other regulated/precision industries strongly preferred.
• Working knowledge of ISO 13485 and GMP concepts; experience maintaining DHRs and working within a documented QMS/eQMS.
• Proficient at reading engineering drawings, GD&T basics, and using common measurement tools.
• Hands-on experience executing established test methods and recording results with lot/serial traceability.
• Familiarity with sampling plans (e.g., ANSI/ASQ Z1.4), basic SPC, and nonconformance workflows (NC, MRB, SCAR).
• Comfortable working on the line, collaborating with operators, technicians, and test engineers.
• Nice to have: exposure to risk management (ISO 14971), ESD/cleanroom practices, and medical device labeling/UDI.

Success looks like

• High first-pass yield and reduced in-line defects through consistent execution of inspections and tests.
• Clear, timely documentation and communication of nonconformances and trends with effective containment.
• Reliable on-time release of conforming outgoing shipments with complete, audit-ready DHRs.
• Tight alignment with production and test teams, with rapid verification of fixes.