Senior ManufacturingQuality Engineering Consultant - Medical Device

Brief Description

About ECI

ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges and we take pride in providing them transformative solutions with distinctive, sustainable and long term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.

About This Role

Support the Manufacturing Engineering Team with Manufacturing Process controls remediation activities. The service will be provided through different roles.

What You'll Do

Key Objectives

Execute remediation tasks to address identified validation gapsUpdate and improve validation documentation to meet current standardsSupport compliant revalidation and documentation effortsEnsure accurate, complete, and traceable validation records

Gap Assessment Support

Assess PRA (Product Risk Assessment) and pFMEAs to detect validation status and IPM (In Process Controls).Review existing validation documentation (OQ/PQ, test methods, software validation, etc.)Identify discrepancies and documentation deficiencies based on provided checklists or guidanceSupport risk assessments by gathering data and documenting findings

Remediation Execution

Revise, update and create validation documents, including: Protocols (OQ/PQ)Validation reportsWork instructions and forms if applicableExecute validation activities such as test runs, data collection, and verification tasksEnsure proper documentation of all testing and results
Documentation & Compliance

Ensure documentation aligns with: U.S. Food and Drug Administration (FDA) requirements (e.g., 21 CFR Part 820 / Part 11 as applicable)International Organization for Standardization standards (e.g., ISO 13485)Internal Quality Management System (QMS) proceduresMaintain accurate, organized, and audit-ready records
Cross-Functional Collaboration

Work closely with Manufacturing and Quality teams to gather inputs and execute tasksCommunicate progress, issues, and risks to project leadsParticipate in team meetings and provide updates on assigned activities

Deliverables

Updated validation protocols and reportsCompleted test execution records and supporting dataDocumented gap assessments (as assigned)Traceability updates and supporting documentationInputs to remediation plans and progress tracking

What We're Looking For

Bachelor’s Degree in Engineering.8 years of experience.Advanced computer skills including MS Office applications (Word/Excel/PowerPoint/Project/Visio) Proficient in the use of Minitab statistical analysis.Experience with SolidWorks, ProE or Inventor, prototypes, 3D (desirable)Familiar with electronic management documentation.Spanish: Native Speaker, English: Fluent speaking, writing and reading.

ECI is an equal opportunity employer.

All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.

Manufacturing Process ImprovementProduct