CAPA Facilitator, Engineer (Medical Devices)

Location: Newark, DE, United States, or Marlborough, MA, United States

Annual base salary: $97,600–$152,700, plus bonus eligibility.

Company

hirify.global develops and supports medical technology and regulated quality systems.

What you will do

• Serve as a CAPA subject matter expert, supporting root cause analysis, effectiveness checks, and sustainable corrective actions.
• Facilitate CAPA Review Board meetings and maintain related documentation, training materials, templates, and resources.
• Monitor CAPA system health, escalations, metrics, dashboards, and performance reporting.
• Support QMS process improvements, remediation projects, quality plans, and continuous improvement initiatives.
• Participate in internal and external audits, including FDA inspections, and support audit readiness.
• Mentor junior team members and provide CAPA training and consultation to cross-functional teams.

Requirements

• 3–8 years of quality assurance and CAPA experience in the medical device, IVD, or pharmaceutical industry.
• Technical bachelor's degree or higher preferred.
• Strong knowledge of QMSR, ISO 13485, and global quality regulations.
• Experience leading cross-functional teams and managing multiple workstreams.
• Strong technical writing, analytical, problem-solving, communication, and organizational skills.
• Understanding of statistics and statistical analysis; experience with Agile or an equivalent product lifecycle management system is beneficial.

Culture & Benefits

• Comprehensive onboarding and continued professional development and training.
• Competitive annual salary and bonus scheme.
• Work focused on accountability, compliance, quality, and continuous improvement.