Quality Engineer 3 - Risk Management

About the role

The Quality Engineer Level 3 – Risk Management is an experienced individual contributor within Regulatory and Quality for Diagnostics. This role is responsible for performing and maintaining product and process risk management activities for medical device and/or in‑vitro diagnostic products across the full product lifecycle. The position supports new product development, sustaining activities, manufacturing, supplier quality, post‑market surveillance, complaints, CAPA, nonconformances, and change management. It partners with cross‑functional teams—including Quality, Regulatory Affairs, R&D, Manufacturing, Customer Service, Commercial/Sales, Supplier Quality, and Post‑Market teams—to ensure risk management activities meet applicable quality system requirements, FDA regulations, ISO 13485, ISO 14971, and other relevant regulatory expectations.

Responsibilities

• Perform assigned risk management activities across product development, manufacturing, sustaining, and post‑market phases.
• Develop, review, maintain, and evaluate risk management documentation and deliverables.
• Assess product, process, software, supplier, manufacturing, service, or labeling changes for new hazards or impacts on existing risk controls.
• Identify, verify, and evaluate the effectiveness of risk controls.
• Interpret technical documentation to identify quality, compliance, or risk implications.
• Produce clear, objective, technically accurate, inspection‑ready documentation.
• Support cross‑functional design reviews, change review boards, CAPA teams, complaint investigations, and material review activities.
• Provide subject‑matter input during audits, inspections, and readiness activities.
• Manage multiple priorities and meet project timelines in a regulated environment.
• Maintain audit and inspection readiness for internal audits, external audits, regulatory inspections, and supplier audits.

Skills

• Independent execution of risk management tasks throughout the product lifecycle.
• Development and maintenance of risk management files, hazard analyses, DFMEA, PFMEA, safety risk analyses, and benefit‑risk evaluations.
• Ability to assess the impact of changes on risk controls and to verify control effectiveness.
• Strong analytical thinking, problem‑solving, root‑cause analysis, and risk‑based decision‑making.
• Effective written, verbal, and interpersonal communication.
• Attention to detail and commitment to high‑quality standards.
• Collaboration with stakeholders across Quality, Regulatory, R&D, Manufacturing, Supplier Quality, Customer Service, Commercial/Sales, and Post‑Market teams.
• Objectivity and technical accuracy in risk documentation and assessments.
• Escalation of complex risk questions, safety concerns, or unresolved risk acceptability issues to senior leaders.
• Adaptability to changing priorities while maintaining focus on quality, compliance, and product safety.

Experience

• Bachelor’s degree in engineering, life sciences, biomedical sciences, quality, or a related technical discipline.
• 5+ years of experience in a regulated medical device, IVD, quality engineering, or product development environment.
• Experience supporting risk management files, hazard analyses, FMEAs, design control documentation, change control, complaints, CAPA, and nonconformance processes.
• Experience working on cross‑functional teams in regulated product development or sustaining engineering.
• Experience evaluating post‑market information (complaints, deviations, service data, etc.) for potential risk impact.
• Experience supporting internal and external audits, regulatory inspections, supplier audits, and inspection‑readiness activities.
• Practical experience reviewing and maintaining risk files throughout product development, manufacturing, and post‑market surveillance phases.

Compensation

The annualized base salary range for this role is $98,500 – $154,000 and the position is bonus eligible. Final compensation packages will depend on factors such as relevant experience, skill set, knowledge, education, business needs, and market demand.

Hologic is committed to providing comprehensive training upon hire and continued development throughout your career, making it a destination for top talent.