Quality Assurance Quality Control Engineer

QA/QC Engineer
About HealX-Medical

HealX-Medical designs and manufactures medical-device components and sub-assemblies for legal-manufacturer customers. We run the full chain—development, industrialization, and serial production—under one roof, with tight engineering/quality integration and fast execution.

You’re a quality-and-manufacturing engineer, not a checkbox inspector. You prevent escapes by engineering the production system: robust workflows, correct documentation, disciplined change control (ECO/DCO), and a production line that is qualified/validated and stays that way.

• Gate shipment: verify configuration, test evidence, traceability, labeling/packout, and DHR completeness/accuracy.
• Detect and stop problems early: incoming/in-process/final controls; containment when evidence is weak.
• Own nonconformities: NCR/MRB workflow, dispositions, and verification of rework/repair effectiveness.
  

• Initiate and drive ECOs/DCOs: rationale → impact assessment → document updates → implementation → training → verification/effectiveness.
• Update production documentation as part of the change (work instructions, test instructions, routings, forms/templates, acceptance criteria).

• Improve, simplify, and correct production flows to remove failure modes (especially traceability, data integrity, and release mechanics).
• Reduce friction without weakening compliance: fewer steps, fewer handoffs, clearer controls, higher right-first-time.

• Co-own production process validation and the maintained validated state using standard industry terminology:
• IQ: equipment/fixtures/test stations installed and documented correctly (incl. calibration/maintenance readiness).
• OQ: process/test station operates within defined limits and acceptance criteria.
• PQ: process performs consistently under normal production conditions (operators/shift coverage as applicable).
• Drive deviation handling and validation rework when outcomes or evidence are insufficient.
• Own change impact decisions: when a change requires partial or full re-qualification/re-validation (re-IQ/re-OQ/re-PQ).
  

• Strong engineering affinity: can read drawings/specs, understand test setups, and reason about failure modes and measurement integrity.
• Proven QA/QC experience in regulated electromechanical manufacturing (medical devices strongly preferred).
• Demonstrated ownership of ECO/DCO or equivalent controlled change processes.
• Hands-on experience with production process validation/qualification using IQ/OQ/PQ (not just “paper”).
• ISO 13485 environment experience; comfort with audits and objective evidence.
• High standards for data integrity and traceability; treats documentation errors as product defects.
• Can apply “stop-ship” judgment when needed.
  

• Experience with supplier quality (incoming quality plans, SCARs, supplier corrective actions).
• Experience with test stations for electronics, RF/EMS, pumps/valves, or similar subsystems.
  

• Release escapes go to ~zero (product, configuration, and DHR align every time).
• ECO/DCO cycle time improves while defects and rework drop.
• Production validation evidence is clean, retrievable, and resilient to change (right level of re-IQ/OQ/PQ when needed).