Senior Process Engineer, Quality & Compliance (QMS)

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

Job summary

GRAIL is seeking a Senior Process Engineer in Durham, NC to lead QMS activities across engineering, validation, and operations, ensuring regulatory compliance and continuous improvement. You will drive change control, document control, CAPAs, and training programs while collaborating with QA, Regulatory Affairs, and Manufacturing to sustain excellence.

The role is full-time onsite with opportunities to influence process excellence, audits readiness, and cross-functional collaboration in a

Qualifications

• Bachelor’s degree in Engineering with 5+ years of relevant experience, or Master’s degree with 3+ years, or PhD with 2+ years of relevant experience.
• Knowledge of GMP/QMS standards (e.g. ISO 13485) and clinical laboratory regulations (CAP, CLIA, NYSDOH, ISO 15189).
• Experience supporting audits, inspections, and regulatory readiness activities.
• Ability to manage multiple priorities and drive projects to completion in a fast-paced regulated environment.

Responsibilities

• Lead and own quality management system (QMS) activities, including change controls, document control, SOP revisions, deviations/nonconformances (NCs), and corrective and preventive actions (CAPAs).
• Develop and maintain work instructions, guidelines, verifications, and standard operating procedures.
• Independently investigate and resolve process deviations, applying root cause analysis and implementing effective corrective and preventive actions.
• Support internal audits, external inspections, and regulatory assessments; prepare documentation, evidence packages, and responses to audit observations.
• Partner cross-functionally with QA, Regulatory Affairs, Engineering Operations, Validation, and Clinical Operations leadership to implement and sustain compliant processes.

Skills

Regulatory compliance

QMS experience

Root cause analysis

Cross-functional collaboration

Documentation control

Education

Bachelor’s degree in Engineering

Master’s degree

PhD

Job description

GRAIL is seeking a Senior Process Engineer in Durham, NC to lead QMS activities across engineering, validation, and operations, ensuring regulatory compliance and continuous improvement. You will drive change control, document control, CAPAs, and training programs while collaborating with QA, Regulatory Affairs, and Manufacturing to sustain excellence.

The role is full-time onsite with opportunities to influence process excellence, audits readiness, and cross-functional collaboration in a