Quality Engineer; Operations

We are a leading contract manufacturer specializing in high-end medical device prototyping, development, and manufacturing. Our cutting-edge capabilities focus heavily on balloon catheters, advanced delivery systems, reinforced/steerable catheters, nitinol components, and biomedical textiles.

We are seeking a data-driven, collaborative Quality Operations Engineer to join our team on the production floor. In this role, you will bridge the gap between our customers and manufacturing teams, ensuring line issues are resolved quickly and robust continuous improvement methodologies are implemented to optimize efficiency.

• Operational Quality Representation: Function as the dedicated quality customer representative as complex product projects transition from design directly into manufacturing.
• Design Transfer & Production Readiness: Support design transfers, verify line readiness for full-scale production, and ensure all strict quality system requirements are fully executed.
• Issue Resolution & Troubleshooting: Lead rigorous investigations for NCMRs, customer complaints, and CAPAs; troubleshoot active manufacturing problems to ensure total compliance with procedures.
• Cross-Functional Collaboration: Partner with cross-functional teams to review and determine the disposition of nonconforming components, and collaborate with suppliers on SCARs and material defects.
• Validation &
  
  Risk Management:
  
  Generate and execute comprehensive process validation protocols and reports (IQ/OQ/PQ) and manage process risk files (
  pFMEA
  ).
• Compliance & Auditing: Review completed Device History Record (DHR) documentation with a high degree of accuracy to ensure perfect Good Documentation Practices (GDP) and completeness.
• Strategic Advisory: Support, advise, and mentor internal project teams on proper execution of Quality Policies and Verification procedures.

• Education: Bachelor of Science (B.S.) degree in Engineering, Science, Technology, or a closely related STEM field.
• Industry
  
  Experience:
  
  Minimum of 5+ years of dedicated experience working in the medical device manufacturing industry.
• Quality Functional
  
  Experience:
  
  3 to 5 years of direct experience working in a Quality Engineering role.
• Preferred Product Background: Strong hands‑on experience or familiarity with catheter assembly (balloon catheters, delivery systems, or extrusion) is highly preferred.
• Regulatory Compliance: Working, practical knowledge of medical device regulations, specifically FDA 21 CFR Part 820, ISO 13485, and ISO 14971.
• Technical Toolbox: Strong functional application of manufacturing risk management (
  pFMEA
  ) and engineering line validation (IQ/OQ/PQ).

We are committed to diversity and inclusivity in our hiring practices.