Quality Assurance Engineer 2

Job description

Join Hologic as a Quality Engineer in a regulated medical device environment, responsible for ensuring products, processes and systems meet internal quality requirements and external regulatory standards (e.g., FDA, ISO). The position supports Operations, Engineering and R&D, focusing on defect prevention, continuous improvement, and robust manufacturing practices. Knowledge: - Quality Management Systems (QMS) for medical devices - GMP, GDP principles and basic regulatory frameworks - Medical device Quality System Regulations (21 CFR 820), ISO 13485, MDD (beneficial) - Risk management, risk assessments and documentation updates - Nonconformance (NCE), CAPA, SCAR, MRB processes - Inspection, testing and validation methods for products and processes - Statistical analysis and scientific method (beneficial) - Basic understanding of microbiology, molecular biology, biochemistry, chemistry, or related fields (beneficial) - Nucleic acid amplification and detection technologies (beneficial) - Company quality system requirements and standards Skills: - Strong computer literacy: word processing, spreadsheets, databases - Ability to develop and implement procedures, inspection procedures and...