Job Description
The Quality Application Specialist supports quality and product transfer activities within a regulated medical device manufacturing environment, with primary responsibility for process validation and product commercialization efforts. This role ensures compliance of quality systems, manufacturing processes, and computerized systems with applicable FDA and international regulatory requirements. Key Responsibilities: Support product transfer activities from development through commercial release. Execute and maintain process validation lifecycle activities, including protocol development, execution, analysis, and reporting. Conduct validation activities for quality information technology systems, ensuring compliance with applicable regulatory requirements. Develop, review, and maintain validation documentation, including SOPs, validation plans, protocols, reports, and supporting records. Support sterilization processes and validation activities to ensure compliance with established stand...