Quality Product & Process Controls Engineer (12‑month contract)

About the role

We are seeking a Quality Product & Process Controls Engineer to lead continuous improvement of quality control and manufacturing processes for medical devices. This 12‑month temporary position will ensure in‑process controls are defined, validated, and maintained in line with regulatory standards and product quality objectives.

Key responsibilities

• Lead and execute continuous improvement initiatives for quality control and manufacturing processes.
• Define, maintain, and validate quality documentation such as control plans, PFMEA, and risk assessments.
• Analyze quality and in‑process data, monitor key indicators, and initiate Non‑Conformance Events, CAPAs, and corrective actions.
• Own investigations related to in‑process controls and report findings to CSPOs.
• Conduct root‑cause investigations, implement effective CAPAs, and reduce process variability.
• Collaborate with Quality Engineering, Manufacturing, R&D, and Supply Chain to establish robust in‑process controls.

Required profile

• Bachelor’s degree in Engineering (Mechanical, Electromechanical, Chemical, or Biotech preferred).
• Minimum 2 years of experience as a technical field professional in a similar role.
• Knowledge of ISO 13485, ISO 14971, and medical device risk management.
• Proven ability to lead critical tasks, assess risks, and communicate findings to stakeholders.

Required skills

• Product and process control requirements.
• ISO 13485 and ISO 14971 compliance.
• Risk assessment methods (PFMEA) and root‑cause analysis.
• Statistical analysis and design of experiments; MiniTab preferred.
• Proficiency in Microsoft Word, Excel, Outlook, and PowerPoint.
• Fluent in Spanish and proficient in English.