Quality Engineer II – Medical Device Manufacturing

About the role

The Quality Engineer II will join the Global Operations & Quality team to ensure regulatory compliance and drive continuous improvement across product development, manufacturing, and distribution of cardiovascular medical devices. You will work closely with manufacturing, engineering, and supply‑chain partners to resolve quality issues and support product releases.

Key responsibilities

• Investigate moderately complex manufacturing quality and compliance issues, including PRAs and complaints.
• Manage site NCRs, CAPAs, ECRs, and audit observations for all production processes.
• Provide technical support for internal and external audits and generate related reports.
• Oversee product release, assess and disposition on‑hold items (MRB), and manage material quality control.
• Review and approve equipment validations and asset‑management actions.
• Apply Six Sigma, TOPP, and Lean methods to optimize manufacturing processes and drive continuous improvement.
• Identify redesign opportunities for equipment, tools, and fixtures to reduce risk.
• Collaborate with engineering teams to ensure successful product transfers.
• Maintain risk‑management files, update pFMEAs, and develop training and work‑instruction documentation.
• Support process validation activities and sustain quality‑engineering responsibilities such as reviewing quality metrics, material review boards, and quality control data.

Required profile

• Bachelor’s degree in Engineering or a scientific field with at least 2 years of relevant experience, or a Master’s degree (or equivalent) with internship, senior project, or thesis experience.

Required skills

• Six Sigma
• TOPP
• Lean methodology
• Risk management
• pFMEA
• Equipment validation
• Process validation
• CAPA management
• NCR handling
• ECR handling
• MRB processes
• Quality metrics analysis
• Material Review Boards