Senior Quality Engineer
Core
Lead process validation and quality system execution for manufacturing operations in a regulated medical device environment.
Role type
Senior Quality Engineer (Manufacturing)
Builds
Compliant, effective, and sustainable manufacturing processes for medical devices
Domain
Healthcare / Medical Devices / Manufacturing
Required skills
Process validation lifecycle management, Root cause analysis (CAPA), Statistical analysis, Regulatory compliance (FDA/CFR), Equipment qualification, Quality documentation, Technical leadership
Preferred skills
Chemical/Biomedical/Mechanical Engineering background, FDA-regulated medical device experience, Minitab, Lean Six Sigma, ASQ CQE certification
Technologies
Minitab
Responsibilities
Lead process validation activities across the full validation lifecycle, Develop and maintain quality standards and manufacturing process requirements, Drive root cause investigations and corrective actions, Analyze quality and process performance data, Develop inspection and testing methods, Support equipment and process qualification, Ensure compliance with regulatory requirements, Mentor quality and engineering colleagues
Seniority
Senior, hands-on IC with mentorship responsibilities