Sr Quality Engineer I

This is a full-time time position to work in our Heredia site located in Zona Franca Metropolitana. 

Our Sr Quality Engineers I, 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.

Responsibilities in detail:

• 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.
• Coordinate the development of new processes inspections by interfacing with personnel from product design and development, quality assurance, production, manufacturing, process/assembly technology and external vendors / customers.
• Review drawings, analyze tooling, and recommend improvements leading to increase productivity, quality, and safety for new or existing manufacturing processes.
• Coordinate and carry out qualification and validation activities for new products, processes, changes and transfers as per FDA regulations (IQ, TMV, OQ, PQ and Quality Plans). Prepare respective validation protocols and reports for moderate and high complexity qualifications or participate in the approval of them.
• Executes investigations for audit non-conformances, complaints and Corrective and Preventive Actions (CAPA) to correct a problem presented in the quality system or the manufacturing process.
• Responsible for the elaboration of risk management documentation such as Risk Management Plan / Report and Process FMEAs.
• Train Quality Assurance Inspectors and manufacturing personnel in understanding of procedures, specifications, environmental controls, etc.
• Act as a quality system internal auditor. Participate in communicate with the customers including weekly sustaining report out meetings, QBRs, projects meetings, other.
• Assure that all laboratory equipment is in compliance to perform the analysis and testing activities (quality labs, calibration, microbiology and incoming).
• Prepare respective validation protocols and reports for low and moderate complexity qualifications or participate in the approval of them. Participates on the definition of validation strategies.
• Elaboration of Validation Master Plans to define / document all the validation strategy required to implement a new product / process or change a current one. Also, elaborate the Validation Master Plan Closure once all the activities have been executed
• Read and interpret technical drawings provided by the customer and elaborates the related documentation such as of QA Specs, Control Plans, other.
• Elaboration of work instructions, automated routines or any other document required to execute inspections. Also, validate these inspections through TMV Protocols and TMV Reports..
• Participate in the communications with the customers including projects, product/process transfers, weekly sustaining report out meetings, Quarterly Business Reviews, other.
• Provide new hire introduction sessions. (Quality Process and Quality Systems Engineer only).
• Create quarterly suppliers' evaluation, scorecards. (Supplier Quality Engineer only).
• Purchasing control of approved suppliers through the document change control process. (Supplier Quality Engineer only).
• Prepare and update quality documents and any applicable documentation required to sustain the manufacturing process, system or NPI projects, including but not limited to documentation linked to the Device Master Records and Device History Records.
• Execute reviewing / approval of any documentation created / updated by the Manufacturing Engineering department (or other) required to sustain the manufacturing process or quality systems.
• Support in analysis, review and implementation of new methodologies, processes, tools that contribute to the improvement on the manufacturing process, quality systems or supplier improvements.
• Checks, provides support and executes initiation / investigation for NCs, Complaints, Calibration, SCARs and Environmental Monitoring.
• Provide follow up to actions generated from corrective and preventive plans.
• Performs other duties, tasks, or projects at the direction of the immediate supervisor or other teammates.
• Maintain and follow up CAPA and supplier files. (Quality Systems and Supplier Engineer only).
• Support in the execution of qualifications (IQs/OQs/PQs/PPQs/TMVs) with an approved protocol; gather data and analysis results for completing the corresponding report.

Minimum Requirements:

• 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.
• 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:

• 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.
• Metrology: Capable of developing measuring procedures and test methods, selecting test equipment, measuring instruments and validating test methods.
• 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.
• Effective presentation skills and ability deliver insightful messages to external and internal audiences.
• Effective planning and time management
• Self-starter willing to take calculated risks.
• Demonstrated leadership and motivational skills.
• Must be flexible and adapt to changing environments and priorities.
• Hands-on, collaborative, decisive. Customer oriented. Results oriented. Analytical. Innovative. Leadership. Proactive. Discipline. Customer oriented. Team player. Diligent. Retentive. Good learner