Quality engineering consultant ii - medical device #2104

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

This role supports the Quality department by providing sustaining quality engineering support for existing medical device manufacturing operations to maintain product conformity and adherence to the company’s Quality Management System.

What You'll Do

Responsibilities:

• Assess manufacturing quality issues and coordinate containment of potentially affected product.
• Support nonconformance investigations, root cause analysis, and corrective and preventive actions (CAPA).
• Monitor defect trends, inspection results, and recurring quality problems.
• Review manufacturing changes for quality impact, risk considerations, and required controls.
• Review validation protocols and reports, and assess the effectiveness of corrective actions.
• Support audits, maintain assigned quality documentation, and supervise the Apprentice Engineer’s quality-related assignments.

Deliverables:

• Completed quality investigations, CAPA support records, quality trend summaries, change and validation reviews, and audit evidence.

What We're Looking For

• Bachelor’s Degree in Engineering.
• 4 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.

Languages:

• 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.

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