Quality Engineer II
Core
Support manufacturing operations for surgical sutures through process validation, quality system execution, and maintenance of quality standards.
Role type
Quality Engineer II (Manufacturing)
Builds
Compliant and reliable medical device manufacturing processes
Domain
Medical device manufacturing / Surgical sutures
Required skills
Process validation, Quality system execution, Statistical analysis, CAPA, Inspection and testing methods, Quality documentation compliance
Preferred skills
Chemical/Biomedical/Mechanical Engineering background, Minitab, Six Sigma, IQ/OQ/TMV/PQ experience
Technologies
Minitab
Responsibilities
Develop and maintain quality standards and protocols for manufacturing processes; Execute process validation activities across the validation lifecycle; Partner with Engineering and Manufacturing to resolve product and process quality issues; Develop and implement inspection, testing, and evaluation methods; Investigate nonconforming products and support corrective and preventive action (CAPA) activities; Ensure corrective measures meet reliability standards and documentation compliance.
Seniority
Mid-level, hands-on IC