Quality Engineer 2

Hologic is seeking a Quality Engineer II to ensure compliance and quality throughout the manufacturing lifecycle of diagnostic and medical device products.

Requirements

• Proficient understanding of validation methods
• Knowledge of risk analysis tools such as PFMEA and process risk assessments
• Working knowledge of regulatory requirements, including 21 CFR Part 820, ISO 13485, ISO 14971, and 21 CFR Part 11
• Familiarity with change control processes and documentation requirements
• Understanding of statistics, Statistical Process Control (SPC), and acceptance sampling plans
• Strong technical writing skills
• Ability to perform validation impact assessments and determine risk-based validation strategies
• Experience with electronic document management systems
• Proficient in leading cross-functional teams
• Excellent analytical and problem-solving skills
• Strong interpersonal and collaboration skills
• Project management skills

Benefits

• Comprehensive training and development opportunities
• Bonus eligibility