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Quality Assurance Specialist

1 month ago

Peachtree City, Georgia, United States Gerresheimer Full time

{"h1": "Job Title: Quality Engineer", "h2": "Job Summary", "p": "Gerresheimer is a global partner for pharmaceutics, biotech, healthcare, and cosmetics. We are seeking a Quality Engineer to join our team in Peachtree City, GA. The successful candidate will be responsible for planning and overseeing risk management activities for medical devices, including A-Risk Analysis, D-DMEA, and P-FMEA, in compliance with ISO 14971.", "ul": ["Independently plan and oversee risk management activities for medical devices, including A-Risk Analysis, D-DMEA, and P-FMEA, in compliance with ISO 14971.", "Collaborate with risk management staff to conduct risk/FMEA assessments.", "Serve as the primary contact for customers on quality-related matters, ensuring efficient coordination and communication.", "Define and implement validation strategies based on regulatory and customer requirements, following a risk-based approach, and document them in VMP and CRS/PRS.", "Oversee validation activities, ensuring alignment with the validation master plan, product specifications (CRS), and qualification/validation plans.", "Establish and execute criteria for visual inspections of parts and assemblies during qualification and validation activities.", "Plan and manage product design verification activities independently.", "Define quality requirements for purchased parts and coordinate with suppliers to ensure compliance with these standards."]}