Quality Engineer

Hace 4 semanas

Heredia, Costa Rica Recluta Talent Hunter Jornada completa
Qualification

Requirements:
Bachelor’s degree in a science-related discipline or equivalent. 3+ years of relevant experience in a medical device-related quality function. QMS Auditor Certification is desirable. Fully bilingual in English and Spanish. Knowledge of FDA 21 CFR, ISO 13485, ISO 14971, MDI, etc. Experience in the use and application of statistical tools. Desired experience in internal and supplier auditing. Experience in facilitating external audits (e.g., NSAI, FDA). Instrument calibration knowledge. Proficiency with MS Project, MS Visio, Minitab, etc. Familiarity with measuring hand tools. Technical

Skills:
Expertise in product and process validation, including FMEA, DOE, test method validation, and sampling plan analysis. Proficient in risk management for medical devices and associated tools. Experience with Six Sigma problem-solving methodologies and process improvement. Knowledge in change control and CAPA/non-conformance reports. Strong technical writing skills.