About this role
Quality Engineer 2 at Hologic Careers. Location: United States or Marlborough. Role: leading investigations, implementing CAPA, supporting transfers Requirements: Bachelor's or equivalent, 2+ years quality experience in medical devices, knowledge of ISO 13485, FDA, EU MDR/IVDR, ISO 14971, PFMEA, Six Sigma, SPC, DOE, CAPA and process validation (IQ/OQ/PQ). Category: Quality Assurance Seniority: Entry Level Tools: ISO 13485, EU MDR/IVDR, FDA regulations, ISO 14971, PFMEA, Six Sigma, Statistical Process Control (SPC), Design of Experiments (DOE), Quality Management Systems (QMS), IQ OQ PQ Commitment: Full Time Workplace: Onsite Languages: English