Quality Product & Process Controls Sr Engineer CR
Description:
Quality Product & Process Controls Sr Engineer CR
Alajuela, Costa Rica
+ **Education / Educación:**
Bachelor’s Degree in Engineering or a similar career.
Desirable: Master’s degree
+ **Experience / Experiencia:**
+ 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.
+ **Specialized Knowledge (Desirable) / Conocimiento especializado (preferible):**
+ 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:**
+ Proficiency skills in Microsoft Word, Excel, Outlook, PowerPoint, and other office software programs.
+ MiniTab preferred
+ **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:**
+ Problem solving
+ Understanding others
+ Decision quality
+ Peer relations
+ Organizational agility
+ Drive for results
+ Planning & Informing
+ Communication
+ 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.