Sr Quality System Engineer 1

  This is a full-time position to work Monday to Friday from 8am to 5pm in our Heredia site located in Zona, Franca Metropolitana. Remote work might be allowed based on business needs.   Main Purpose of Job: Provide Quality Engineering support to the development and production of Class I, II and III (as applicable) Medical Devices. Represent Quality in production process efforts, quality planning, process validations, FMEA and Risk Analysis, support new product development activities, maintain and manage quality compliance and supplier quality management. Support finished goods variance investigation and resolution, complaint investigation, process improvement and quality assurance testing methodology. Participate in or lead Corrective/Preventive Action initiatives. Support internal/ external and suppliers audit, vendor qualification and training programs. Participate in Quality/ Business initiatives including business process improvement activities, documented Quality System re-architecture and other cross-functional projects.   Main Job Duties/Responsibilities All duties listed for category 1, 2 and 3. Participate in Internal / External / Customer / Supplier Quality System audits including all the readiness activities and documents explanation to auditors. Act as a quality system internal and external auditor. Responsible for the preparation of quality metrics required for Management Review, Operations Review or Quality Metrics meetings. Participate and lead communications with the customers including weekly sustaining report out meetings, QBRs, projects meetings, other. Assess compliance with applicable regulations within the manufacturing processes and recommend improvements to ensure that safe and effective products are produced. Monitoring systems by becoming familiar with applications and critical process steps; and through familiarization with methods used to reduce process variation. Manage and lead staff (quality inspectors / technicians / specialists / supervisors) to obtain company goals, including defining and communicating expectations and assignments, monitoring results, coaching, motivating and following up to achieve goals. Coordinate projects and act as a leader for all assigned project activities within the quality department. Administration of approved vendor list (AVL). (Supplier Quality Engineer only). Create and administrate supplier and internal audit schedules. (Quality Systems and Supplier Engineer only). Review validation strategies against quality system regulation and lead quality engineering teams for the execution of validation plans for assigned quality projects. Review validation protocols and reports for categories 1, 2 and 3. Provide technical training and support to Quality Engineers within categories 1, 2 and 3 as well as to Engineering Assistants and Manufacturing Engineers. Be acknowledged as a subject matter expert (SME) in at least one quality subsystem (i.e. process/software validation, complaints, NC’s, other) required to providing support to the Viant Costa Rica campus.    Knowledge / Education   Minimum education required to perform duties: Bachelor degree in Engineering or Science (such as Pharmacy, Microbiology, Physics and Chemistry). Bilingual English/Spanish – Advanced English level (written and spoken), technical writing and capable of leading presentations Intermediate level of knowledge of applicable regulations for the medical device industry (FDA, ISO, etc.) Knowledge and application of risk management (PFMEA’s). Intermediate level of knowledge in process validation and software validation. Intermediate knowledge and application of statistical techniques (Gage R&R’s, Sampling Plans, Hypothesis Test, Statistical Process Control {SPC}, Process Capability Studies, Design of Experiments {DOE}).). Knowledge of Six Sigma Methodology and Lean Manufacturing. Knowledge in root cause analysis tools Proficiency in the use of MS Project.Intermediate level of knowledge of Minitab statistical software. Certified Internal Quality Auditor Certified Quality Engineer or Black Belt is a plus. Certified Lead Auditor is a plus Job Experience  At least 4 years work experience in manufacturing environment. Project Management experience. Experience within the medical device manufacturing or pharmaceutical fields, or any other highly regulated industry (i.e. food, aerospace, etc.) is a plus.   Skills / Competencies Good interpersonal skills and the ability to communicate orally and in writing.Self-motivated. Organized and able to manage multiple tasks and priorities.Must be able to read and understand specifications. Proficient in the interpretation of technical drawings.Must be able to work and effectively communicate with others.Highest ethical standards and professional integrity. Able to work independently.Teamwork oriented.Decision making: Must be able to quickly and independently make decisions.All skills and competencies listed for categories 1, 2 and 3.Proficiency in at least one manufacturing technical field or any quality subsystem (i.e. process/software validation, CAPA system, statistical techniques, risk management, other.) acquired through either formal training and/or work experience.Problem Solving: Must be able to formulate and implement mitigations or corrective actions for identified root causes. Decision making: Capable of making higher risk decisions within specific value streams.