Quality Assurance Engineer 2

Hologic • Newark, NJ

2d

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

• 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
• 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
• Familiarity with Oracle and Agile systems (beneficial)
• Certified Quality Engineer (beneficial)
• 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
• Working in regulated environments, ideally FDA‑regulated or medical devices (beneficial)
• 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)

Benefits

• We are committed to making Hologic the destination for top talent.
• For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level