Senior Process Engineer - Compliance #4968

GRAIL•Durham, NC

1d•$95,000 - $125,000•Onsite

About The Position

The Senior Process Engineer leads complex investigations, compliance related initiatives and supports document management processes. This role is primarily responsible for driving quality management system (QMS) activities across engineering, validation, clinical laboratory and operations, including change control management, SOP lifecycle oversight, nonconformance (NC) and CAPA metrics management, training compliance, and continuous process improvement. The Senior Process Engineer works across functions to design and implement process improvements, serve as a technical resource to peers and technicians, and ensure compliance with regulatory and quality requirements. In addition, this role provides advanced technical expertise in high-complexity molecular diagnostic workflows supporting the Galleri® assay and collaborates cross-functionally to ensure operational excellence, regulatory readiness, and sustained compliance with applicable regulatory and accreditation requirements. This position works full time onsite in Durham, NC.

Requirements

Bachelor’s degree in Engineering (Chemical, Mechanical, Industrial, or related field) with 5+ years of relevant experience, or Master’s degree with 3+ years of relevant experience, or PhD with 2+ years of relevant experience.
Demonstrated level of knowledge regarding applicable regulatory standards commensurate with the position's complexity and scope, contributing to organizational regulatory compliance. Minimal applicable standards for this position include: GMP quality management systems (e.g. ISO 13485), Clinical laboratory regulations (e.g. CAP, CLIA, NYSDOH, ISO 15189), Operations within the regulated medical device environment (e.g. IVDD, IVDR, FDA 21 CFR 800 series, FDA 21 CFR Part 11)
Experience supporting audits, inspections, and regulatory readiness activities.
Proven ability to manage multiple priorities and drive projects to completion in a fast-paced regulated environment.

Nice To Haves

Strong working knowledge of quality management systems (QMS) and regulated laboratory/manufacturing operations.
Expertise in change control, CAPA management, deviation/nonconformance investigations, and document control processes.
Strong analytical and organizational skills with the ability to manage metrics, trend data, and compliance reporting.
Excellent written and verbal communication skills, including technical writing and audit documentation.
Strong collaboration and stakeholder management skills across cross-functional teams.
Process improvement mindset with demonstrated success driving operational and quality improvements.
Experience in executing within computerized maintenance/calibration equipment management systems.
Excellent communication skills to influence and collaborate across departments and present technical findings.
Leadership skills to mentor junior engineers and lead cross-functional teams.
Strong project management and organizational skills; able to manage multiple workstreams with competing priorities

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 Quality Assurance, Regulatory Affairs, Engineering Operations, Validation, and Clinical Operations leadership to implement and sustain compliant processes.
Identify process gaps, compliance risks, and operational inefficiencies; recommend and implement sustainable corrective actions and process improvements.
Mentor and train personnel on workflows, quality processes, and regulatory expectations.
Provide technical guidance and support to engineers and technicians to promote process understanding and standardization.
Prepare and present technical reports, proposals, and recommendations to management for process enhancements and cost savings.
Develop training compliance processes, including assignment, completion tracking, and on the job training assessments.