Quality Product & Process Controls Engineer 2 CR (Temporary 12 months)

• Bachelor’s Degree in Engineering or a similar career. Mechanical Eng, Electromechanical Eng, Chemical, Biotec Eng desirable

   

• 2-year experience minimum as a technical field professional and in similar positions.

   

• Experienced with Product and process Control requirements, ISO 13485 and Medical Devices Directive.
• Experienced with ISO 14971, Risk Management.
• Ability to effectively work with teams, including taking leadership role on critical tasks to assure appropriate and timely completion/resolution.
• Strong ability to assess risks to define appropriate in-process controls, ensure thorough documentation as a principal advocate for compliance, and effectively communicate risk assessments to stakeholders.
• Knowledge of root cause failure analysis, statistical methods, and design of experiment.

• Competency in statistical analysis and tools (MiniTab preferred).

   

• Spanish and 90% English   

• Proficiency skills in Microsoft Word, Excel, Outlook, PowerPoint, and other office software programs.
• MiniTab preferred

Lead and/or perform continuous improvement of quality control and manufacturing processes, ensuring that in-process controls are clearly defined, implemented, optimized, validated, and maintained in compliance with internal standards, applicable regulations, and product quality objectives.

• Define and maintain adequate quality documentation, including control plans, risk assessments (such as PFMEA), and other relevant records to ensure compliance, traceability, and alignment with product and process risks.
• Analyze quality and in-process control data to identify trends, define and monitor key control indicators, and initiate targeted actions such as Non-Conformance Events (NCEs), continuous improvement initiatives, and Corrective and Preventive Actions (CAPAs), ensuring timely and effective resolution of quality issues. Report relevant results to CSPOs and serve as investigation owner for issues related to in-process controls.
• Lead and/or perform root cause investigations and implement effective CAPAs to address quality issues and reduce process variability, ensuring robust containment, correction, and prevention.
• Work in conjunction with Quality Engineering, Manufacturing, R&D, and Supply Chain teams to identify and establish in-process controls that support product development, process validation, and continuous improvement initiatives across products and manufacturing lines.
• Plan, coordinate, and implement process improvements and optimizations in conformance with quality requirements and applicable regulations, with the objective of improving product quality indices and process capability.
• Maintain ongoing communication with all CSPO members (local and/or extended) to facilitate decision-making that impacts product, manufacturing line, and/or project performance, ensuring alignment on risks, controls, and improvement priorities.
• Develop, support, and/or execute validations (e.g., process, methods, equipment) to ensure proper implementation and state of control in conformance with regulations, standards, and good practices, contributing to operational excellence.

• Problem solving
• Understanding others
• Decision quality
• Peer relations
• Organizational agility
• Drive for results
• Planning & Informing
• Communication