Quality Engineering Consultant II – Medical Device

About the 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.

Key responsibilities

• Assess manufacturing quality issues and coordinate containment of potentially affected product.
• Support non‑conformance 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.
• Deliver completed quality investigations, CAPA support records, quality trend summaries, change and validation reviews, and audit evidence.

Required profile

• Bachelor’s Degree in Engineering.
• Minimum 4 years of relevant experience.
• Spanish native speaker and fluent in English (speaking, writing, reading).

Required skills

• Advanced computer skills with MS Office applications (Word, Excel, PowerPoint, Project, Visio).
• Proficiency in Minitab for statistical analysis.
• Experience with SolidWorks, ProE or Inventor, including prototypes and 3‑D modeling (desirable).
• Familiarity with electronic management documentation.