Quality Assurance Engineer 2

Hologic•Newark, DE

About The Position

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.

Requirements

Quality Management Systems (QMS) for medical devices
GMP, GDP principles and basic regulatory frameworks
Risk management, risk assessments and documentation updates
Nonconformance (NCE), CAPA, SCAR, MRB processes
Inspection, testing and validation methods for products and processes
Strong computer literacy: word processing, spreadsheets, databases
Ability to develop and implement procedures, inspection procedures and test methods
Excellent technical writing; able to produce clear quality reports and detailed procedures
Ability to read, analyze and interpret technical procedures, standards, journals and regulations
Effective presentation and communication skills
Good interpersonal skills; able to work with all levels, including in potentially adversarial situations
Models and champions quality values and best practices
Acts with urgency in identifying and resolving quality issues
Uses sound judgment within defined procedures and practices
Focuses on defect prevention, reduction of variation and waste, and continuous improvement
Maintains productive internal and external working relationships
Stays current with industry and technical developments through literature review
Works independently on routine tasks, seeking guidance for new or complex assignments
Engages proactively in cross-functional forums (MRB, NCE, CAPA, SCAR) and regulatory interactions
2–5 years with Bachelor’s degree; 1–2 years with Bachelor’s in a technical field; 0–2 years with a Master’s degree
Supporting Operations, Engineering and R&D in product and process development
Participating in audits and inspections (facility, supplier, Notified Body, FDA)
Handling nonconformances, complaints, root cause analysis and corrective actions
Reviewing and approving ECOs, product changes, verification/validation and sustaining engineering documentation

Nice To Haves

Medical device Quality System Regulations (21 CFR 820), ISO 13485, MDD (beneficial)
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)
Familiarity with Oracle and Agile systems (beneficial)
Certified Quality Engineer (beneficial)
Working in regulated environments, ideally FDA‑regulated or medical devices (beneficial)