Senior Engineer, Quality

About the role

As a Senior Engineer, Quality you will ensure that our cardiovascular medical devices meet regulatory and company standards throughout development, manufacturing and distribution. You will work closely with cross‑functional teams to investigate product quality issues, drive continuous improvement and support product release.

Key responsibilities

• Investigate manufacturing product quality and compliance issues, including PRAs, complaints, NCRs, CAPA, ECRs and audit observations.
• Provide technical support for internal and external audits and develop related reports.
• Apply Six Sigma, TOPP and Lean methods to optimize manufacturing and R&D processes and drive continuous improvement.
• Identify redesign opportunities for equipment, tools and fixtures to reduce risk and improve processes.
• Oversee product release, manage material quality control, assess and disposition MRB items, and support process changes.
• Review and approve equipment validations and asset management actions.
• Maintain risk management files, update pFMEAs and develop training and work instructions for production.
• Lead quality engineering activities such as quality metrics review, material review boards and process validation plans.

Required profile

• Bachelor’s degree in Engineering or related field with 4 + years experience, or Master’s degree with 3 + years experience, or Ph.D. with relevant experience.
• Strong background in medical device manufacturing quality and regulatory compliance.
• Proven ability to lead investigations, manage corrective actions and support audits.

Required skills

• Six Sigma
• Lean
• TOPP
• pFMEA
• Risk management
• Equipment validation
• Process validation
• CAPA management
• NCR handling
• ECR management
• Audit support
• Material Review Board (MRB) processes
• Quality metrics analysis