CAPA Facilitator Engineer Date Posted:

29 September 2026

Closing Date:

October 29, 2026

Recruiter:

Hologic Location:

Newark, Delaware Salary:

USD110,000

to

USD140,000

Job Type & Industry:

Technology Risk Contract Type:

Permanent Job Reference:

2992009455-2 Apply for this job now Job Description Hologic is seeking a CAPA Facilitator, Engineer to lead robust Corrective and Preventive Action (CAPA) activities that support our mission of improving women's health. In this role, you will own cross-functional CAPA investigations, perform detailed root cause analyses, and drive effective corrective and preventive actions for medical devices and diagnostic products. You will ensure CAPA records meet FDA and

ISO 13485

requirements, prepare metrics and reports, and support internal and external audits. Partnering closely with engineering, manufacturing, quality, and regulatory teams, you will standardize CAPA processes, train stakeholders in problem-solving tools, and lead continuous improvement initiatives that enhance product quality, patient safety, and compliance in a collaborative, innovation-driven environment. Responsibilities Lead and facilitate CAPA investigations for quality issues in medical devices and diagnostics Analyze root causes, define corrective and preventive actions, and verify effectiveness Ensure CAPA records comply with

FDA, ISO

13485, and company quality system requirements Collaborate with engineering, manufacturing, quality, and regulatory teams to resolve issues Develop and maintain CAPA metrics and reports for management review Support audits and inspections by providing CAPA documentation and status updates Standardize CAPA processes, templates, and best practices across the organization Train cross-functional teams on CAPA methodology and problem-solving tools Use data analysis and risk management tools to prioritize and monitor CAPAs Drive continuous improvement projects to enhance product quality and patient safety Required Skills CAPA management Root cause analysis (5-Why, Fishbone, FMEA) Medical device quality systems (21 CFR 820, ISO 13485) Regulatory compliance documentation Data analysis and reporting Risk management and FMEATechnical writing for quality records Audit support and remediation Statistical analysis tools (e.g., Minitab) Continuous improvement and Lean/Six Sigma