Quality Product & Process Controls Sr Engineer CR

Education / Educación: 

Bachelor’s Degree in Engineering or a similar career.

Desirable: Master’s degree

• Experience / Experiencia: 
• Specialized Knowledge (Desirable) / Conocimiento especializado (preferible): 
• Minimum of 5 years of experience as a university graduate (bachelor’s degree) in positions with a similar level of responsibility. A medical device process and/or product manufacturing environment is preferred.
• Recognized expertise within a similar organization in manufacturing process controls and root cause investigations.
• 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).
• Languages ​​required for the position (Desirable) / Idiomas requeridos para el puesto (preferible): 

Spanish/Fluent English

• Computer tools and knowledge level required (Desirable) / Herramientas informáticas y nivel de conocimiento requerido: 
• Summary of Duties and Responsibilities / Resumen de funciones y responsabilidades:
• Essential duties are listed in order of greatest importance. The incumbent may be asked to perform other function-related activities in addition to the below-mentioned responsibilities as reasonably required by business needs:
• Qualifications / Cualificaciones: 
• Implement quality control processes across products and manufacturing operations, ensuring that in-process controls are clearly defined, implemented, and maintained in compliance with internal standards and regulatory requirements.
• Develop, implement, and continuously refine process control methodologies to proactively monitor, analyze, and enhance product quality and reliability throughout the manufacturing lifecycle. 
• Lead and/or perform root cause investigations and implement corrective and preventive actions (CAPAs) to address quality issues and reduce process variability.
• 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.
• Define adequate quality documentation, including control plans, risk assessments (such as PFMEA), and other relevant records to ensure compliance and traceability.
• Develop and deliver training programs to ensure team members are knowledgeable and proficient in process control methodologies, standards, and best practices.
• Analyze quality data and metrics to identify trends, develop and implement in-process control indicators, drive improvements, and report results to CSPOs.
• Evaluate trend data from in-process controls to 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. Serve as an owner for investigations related to in-process controls.
• Participate in regulatory inspections and audits, providing expertise and support on topics related to process controls and quality systems.
• Promote and lead initiatives to strengthen a culture of quality across the organization, leveraging process control best practices, continuous improvement, and team engagement.
• Proficiency skills in Microsoft Word, Excel, Outlook, PowerPoint, and other office software programs.
• MiniTab preferred           
• Problem solving
• Understanding others
• Decision quality
• Peer relations
• Organizational agility
• Drive for results
• Planning & Informing
• Communication