Senior Engineering Consultant - Quality - 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

Technical Review and Challenge

Perform independent technical reviews of engineering, manufacturing, and quality documentation.Provide objective technical challenge to proposed solutions, process changes, risk assessments, and validation activities.Evaluate technical justifications to ensure they are scientifically sound and compliant with applicable regulations and internal procedures.Identify quality risks and recommend appropriate mitigation actions.

Documentation Review and Approval

Review and approve quality system documentation, including but not limited to: Validation protocols and reportsRisk management documentationEngineering change documentationNonconformance investigationsCAPAs (Corrective and Preventive Actions)Standard Operating Procedures (SOPs)Work InstructionsTechnical reports and quality recordsVerify documentation completeness, accuracy, consistency, and compliance prior to approval.
Quality and Regulatory Compliance

Ensure compliance with applicable regulations and standards, including FDA 21 CFR Part 820 (or QMSR, as applicable), ISO 13485, and internal Quality Management System requirements.Support internal and external audits by providing documentation and technical expertise.Ensure documentation supports regulatory expectations and inspection readiness.

Cross-Functional Collaboration

Collaborate with Manufacturing, Quality Assurance, Regulatory Affairs, R&D, Process Engineering, and Operations teams.Participate in design and process reviews as the quality representative.Provide technical guidance on quality-related issues during project execution.

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