Job Description
Job Description:
Quality role to support product transfer activities, mainly focus on process validation and release product up to commercial release. Experience with process failure mode analysis and first time quality.
TECHNICAL SKILLS
Must Have
10+ years of experience in the medical device industry, with a strong background in field corrective actions, CAPA, or product quality management. Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, EU MDR, and other relevant medical device regulations. Proven experience leading FCA and CAPA processes, ideally within a medical device or regulated industry. Strong project management skills, with the ability to manage multiple priorities and deadlines. Excellent problem-solving and analytical skills, with the ability to ...