Sede: Heredia | Publicado 30 Abril
Software Test Engineer II
This position includes the creation and execution of manual test scripts, unit test, automated writing of test scripts and interaction with a variety of electronic equipment in the lab. Besides manual testing, you might be involved in test automation which requires coding skills in Python or C++. Our tools include Squish, MATLAB and Linux.
Sede: Coyol | Publicado 26 Abril
Business Systems Analyst
• Collaborate with cross-functional teams to analyze business processes, identify opportunities for improvement and develop innovative solutions • Understanding of the software development lifecycle and methodologies specifically the system change management process • Experience with Agile methodology to provide support on issues during Sprint and validation cycles • Attends all scrum events as required or needed. • Leverage technology systems to support the company’s success and overall goals. • Prior knowledge of application interconnectivity and system integrations, capable of learning rapidly to fill any knowledge gaps.
Sede: Heredia | Publicado 26 Abril
Packaging R&D Engineer (Turno B)
The Packaging Engineer will support R&D China Sustaining Engineering and collaborate with various departments to ensure effective packaging design and processes. Responsibilities include packaging design and processes, interaction with various departments and vendors, and complying with FDA regulations, ISO standards, and company policies, supporting projects, writing validation protocols, conducting package testing, maintaining specifications, communicating project timelines, and troubleshooting production issues. Interfacing with internal customers and assisting in root cause analysis, as well as training assemblers and technicians as needed.
Sede: Heredia | Publicado 26 Abril
Labeling Project Specialist (Turno B)
The Labeling Project Specialist will support R&D China Sustaining Engineering organization and collaborate with various departments to ensure effective labeling design & processes. Responsibilities include coordination and creation of the packaging and labeling artwork as well as the supporting functions for review and approval of artwork and content. Works to assure all labeling is correct and follows applicable regulatory requirements. Coordination and creation of the data to the labeling database and labeling format using corporate labeling software. Acts as a resource for product development teams with creating content for Directions for Use manuals. Responsible for coordination/creation of the formatted Directions for Use with the Corporate Run Team or on site design. Responsible for the coordination of translations for labeling and Directions for Use using translation vendors. Responsible for review and Change Request activities for the approval and release of labeling, Direction for Use and other packaging components. Communicate with outside vendors regarding packaging artwork and proofing. Responsible for maintenance of all Packaging Graphics filing systems, paper based and on line.
Sede: Heredia | Publicado 25 Abril
Talent Acquisition Specialist
Carry out the recruitment and selection process, in order to provide potential candidates to fill the different vacancies of the organization, through interviews by competencies. Identify, attract and enhance the internal talent of the organization, in accordance with the guidelines and guidelines established by the management and direction of Human Resources.
Sede: Heredia | Publicado 25 Abril
Designer I
Responsible for modeling/designing components for new and existing medical device products (e.g.assemblies/equipment/fixtures/programmers/leads/stents) into detail drawings and documentation using CAD and other tools.
Sede: Coyol | Publicado 18 Abril
Technician II, Laboratory
Participation in Problem-Solving sessions and understanding of Root Cause Analysis tools and methodologies (Ishikawa, 6M’s, 5 Why’s). Perform testing associated with respective QA Laboratories (proficient use of QA laboratory equipment) and correctly record data, write and review reports, and communicate results precisely, promptly and in a timely manner. Lead product failure analysis (i.e. significant support on CAPA activities) and involve required assistance if required. Initiate and assist in the investigation and disposition of nonconforming materials, designs and/or systems (when applicable). Create, maintain and update data files, databases, spreadsheets and forms, such as the maintenance of the lab´s record file in order to ensure proper record flow, track and monitor department activities. Assist in developing and qualifying test methods, data sheets, test fixtures, testing equipment, processes and train peers on these areas. (CIS) Conduct complaint investigations as per requirements.
Sede: Heredia | Publicado 18 Abril
Packaging R&D Engineer I
Area of works involves packaging design and processes with interaction between R&D, regulatory, document control, purchasing and outside vendors. Develops a proficient understanding of the FDA regulations, ISO standards and BSC policies and procedures. •Supports project work by performing any of the following supports Package Engineering cost savings and improvements projects; writes packaging validation protocols and reports; performs package testing; updates and maintains assigned packaging component, manufacturing and quality specifications; develops and communicates project timetables; other activities of limited scope requiring knowledge of principles and techniques commonly employed in the specific area of assignments. •Demonstrates an understanding of the goals, objectives and strategies of a team/ group, specifically in instances of working with assemblers, production supervisors and engineers in troubleshooting problems on the production floor and in performing MRR investigations. •Interface with internal customers including, QA, QAE, Purchasing, Production, Manufacturing Engineering and other members to resolve packaging issues. Assists in root cause analysis. •Trains assemblers, quality control and technicians, as necessary, on processes, equipment and documentation.
Sede: Coyol | Publicado 12 Abril
Specialist I, Quality
Analyzes customer complaints to determine which are regulatory reportable and coordinates activities with internal, field, and end use customers. Responsible for adherence to Good Manufacturing Practices (GMPs) and proper complaint handling per the Code of Federal Register (CFR) and other governmental regulations. Communicates event investigation results via regulatory reports and written communications, as appropriate.