Senior Process Engineer (Compliance)

Location: Full-time onsite in Durham, North Carolina, United States

Company

hirify.global develops and supports molecular diagnostic technologies, including the Galleri assay.

What you will do

• Lead quality management system activities across engineering, validation, clinical laboratory, and operations, including change control, document control, SOP revisions, deviations, nonconformances, and CAPAs.
• Develop and maintain work instructions, guidelines, verification documents, and standard operating procedures.
• Investigate process deviations, perform root cause analysis, and implement corrective and preventive actions.
• Support internal audits, external inspections, regulatory assessments, and responses to audit observations.
• Identify compliance risks and operational inefficiencies, then implement sustainable process improvements.
• Mentor engineers, technicians, and other personnel on workflows, quality processes, and regulatory expectations.

Requirements

• Bachelor’s degree in Chemical, Mechanical, Industrial, or related Engineering with 5+ years of relevant experience; alternatively, a Master’s degree with 3+ years or a PhD with 2+ years of relevant experience.
• Knowledge of GMP quality management systems, including ISO 13485.
• Knowledge of clinical laboratory regulations, including CAP, CLIA, NYSDOH, and ISO 15189.
• Knowledge of regulated medical device requirements, including IVDD, IVDR, FDA 21 CFR 800 series, and FDA 21 CFR Part 11.
• Experience supporting audits, inspections, and regulatory readiness activities.
• Ability to manage multiple priorities and complete projects in a fast-paced regulated environment.

Nice to have

• Experience with change control, CAPA management, deviation and nonconformance investigations, and document control.
• Experience managing compliance metrics, trend data, and regulatory reporting.
• Experience with computerized maintenance or calibration equipment management systems.
• Project management, stakeholder management, and cross-functional leadership experience.

Culture & Benefits

• Work takes place in office, laboratory, and manufacturing production environments.
• Regular interaction with production equipment and required PPE, including safety glasses, gloves, lab coats, or cleanroom garments.
• Physical work includes frequent standing and walking, occasional lifting of 25–30 lbs, and exposure to chemicals, noise, and temperature variations.
• Flexible hours, overtime, or weekend work may be required for production or project deadlines.
• Benefits include flexible time off or vacation, a 401(k) plan with employer match, medical, dental, vision, and well-being programs.