Quality Engineer – Complaint Focus

Overview

Must be authorized to work. No relocation. US Citizen or Green Card holder.

Join a growing medical device organization focused on quality, compliance, and continuous improvement. This role will play a key part in ensuring externally sourced materials, components and services meet FDA, ISO and internal quality standards.

• Lead investigations into customer complaints, product defects and manufacturing nonconformances, driving root cause analysis and implementing corrective actions. Work cross‑functionally with Manufacturing, Engineering, R&D and Supply Chain to improve processes and prevent recurrence of quality issues.
• Lead investigations into customer complaints and product quality issues.
• Perform root cause analysis and implement CAPA (Corrective and Preventive Actions).
• Conduct risk assessments and ensure timely resolution of quality events.
• Collaborate with cross‑functional teams to resolve manufacturing issues.
• Support customer interactions, audits and regulatory inspections.
• Drive continuous improvement using Lean, Six Sigma and quality tools.
• Monitor quality trends and report performance metrics.
• Maintain documentation and ensure compliance with GMP and ISO standards.
• Work on impactful products in a regulated, high‑quality environment.
• Collaborate with cross‑functional global teams.
• Drive meaningful improvements in product quality and processes.
• Grow your career in a dynamic and innovative organization.

• Bachelor’s degree in Engineering, Life Sciences or related field.
• 5+ years of experience in quality within pharma, biotech or medical devices.
• Experience leading CAPAs, nonconformances and change controls.
• Experience in GMP or cleanroom environments.
• Familiarity with ISO standards and regulatory requirements.
• Experience with Lean/Six Sigma tools is highly preferred.
• Excellent problem‑solving, communication and documentation skills.
• Experience supporting medical device manufacturing, supplier oversight, validation activities (IQ/OQ/PQ), sterilization suppliers and risk management processes.

This role requires current authorization to work in the United States. We are unable to provide visa sponsorship now or in the future.