Senior Process Engineer: QMS & Compliance Lead

GRAIL; Durham (NC); On-site; USD 95,000 - 125,000; Full time

Benefits offered by this job

Flexible time off

401(k) with employer match

Medical, dental, and vision coverage

Well-being programs

Job summary

GRAIL is seeking a Senior Process Engineer to lead complex QMS initiatives across engineering, validation, and clinical operations in a full-time on-site role in Durham, NC. You will drive change controls, document control, CAPAs, and deviation investigations while ensuring regulatory readiness and continuous process improvement.

You will collaborate with QA, Regulatory Affairs, and cross-functional teams, mentor engineers, and provide technical guidance to promote standardization and cost

Qualifications

• Bachelor’s degree in Engineering with 5+ years of relevant experience, or Master’s with 3+ years, or PhD with 2+ years.
• Regulatory standards knowledge (GMP, ISO 13485, CAP, CLIA, NYSDOH, ISO 15189, FDA 21 CFR 800 series, Part 11).
• Experience supporting audits, inspections, and regulatory readiness activities.
• Ability to manage multiple priorities in a fast-paced regulated environment.

Responsibilities

• Lead QMS activities including change controls, document control, SOP revisions, NCs, and CAPAs.
• Develop and maintain work instructions, guidelines, verifications, and SOPs.
• Investigate process deviations using root cause analysis and implement corrective actions.
• Support internal/external audits; prepare evidence packages and responses.
• Partner with QA, Regulatory, Engineering, Validation, and Clinical Ops to ensure compliance.
• Identify gaps and implement sustainable corrective actions and improvements.
• Mentor and train personnel on workflows and regulatory expectations.
• Provide technical guidance to engineers and technicians for process understanding.
• Prepare technical reports and proposals for management.
• Develop training compliance processes including tracking and assessments.

Skills

QMS knowledge

CAPA management

Root cause analysis

Regulatory compliance

Cross-functional collaboration

Auditing support

Training & mentoring

Education

Bachelor’s in Engineering

Master’s degree

PhD

Job description

GRAIL is seeking a Senior Process Engineer to lead complex QMS initiatives across engineering, validation, and clinical operations in a full-time on-site role in Durham, NC. You will drive change controls, document control, CAPAs, and deviation investigations while ensuring regulatory readiness and continuous process improvement.

You will collaborate with QA, Regulatory Affairs, and cross-functional teams, mentor engineers, and provide technical guidance to promote standardization and cost