Engineer 2, Quality Engineering
Core
Ensures quality, reliability, and compliance of medical devices and manufacturing processes throughout the product lifecycle.
Role type
Senior IC Quality Engineer (Medical Devices)
Builds
Compliant medical device products and validated manufacturing processes
Domain
Medical Devices / Manufacturing / Regulatory Compliance
Required skills
Lean, Six Sigma, risk management, process validation, GMP/ISO standards, root cause analysis, data analysis
Preferred skills
FDA and European regulatory standards knowledge, project leadership, cross-functional collaboration
Technologies
Lean, Six Sigma, PDCA, IQ/OQ/PQ, TMV
Responsibilities
Support continuous improvement initiatives using quality tools; Ensure compliance with global regulatory requirements and quality standards; Lead material review activities and manage non-conformances and customer complaints; Support process validation and qualification activities; Evaluate process changes and quality risks to prevent failures; Develop and support quality strategies for product and process validation.