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At Confluent, we are committed to our values of teamwork, innovation, accountability, integrity, leadership, and customer focus, and we invest in a team who represents these values. Every member of our team plays a critical role in delivering life-saving medical devices through innovative materials science, engineering, and manufacturing. We are the medical device industry's most trusted partner, and we accomplish this with an organization focused on safety, efficiency, and customer satisfaction.

We are looking for a Quality Assurance Engineer, Senior Staff to join our team in Costa Rica. If you enjoy working in a fast-paced environment and making an impact on our life-saving work, this may be a good fit for you! As a uniquely qualified candidate, you will:

SUMMARY: Works and leads on problem solving and improvement projects of extend scope where analysis of situation or data requires a review of identifiable factors. Participates in decisions on scope of work, selection of equipment and length of tasks. Analyzes design changes to meet revised specifications during manufacturing. Provides and develops solutions to problems of moderate to complex scope. Must be able to accomplish broad assignments. Provides provides technical guidance to the company. Must be able to write and run manufacturing validation protocols, test method validations and software validation among others. Work on interdisciplinary teams for manufacturing improvement or process transfer projects from different sites as required.

ESSENTIAL DUTIES AND RESPONSABILITIES include the following. Other duties may be assigned.

• Develops, applies, revises and maintains quality standards for processing materials/products into partially or finished products.

• Designs and implements methods and/or procedures for inspecting, testing and evaluating the precision and accuracy of products and/or production equipment.

• Analyzes reports and returned products and recommends corrective action.

• Responds to Supplier Correction Action Responses and determine if vendors need to receive SCARs.

• Prepares documentation for inspection/testing procedures.

• Plans and conducts work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures, and criteria.

• Devises new approaches to problems encountered.

• Responds to common inquiries or complaints from customers, regulatory agencies, or members of the business community.

• Independently performs most assignments with instructions as to the general results expected.

• Receives technical guidance on unusual or complex problems and supervisory approval on proposed plans for projects.

• Plans, schedules, conducts, and coordinates detailed phases of engineering work in part of a major project or in a total project of moderate to complex scope.

• Performs work which involves conventional engineering practice but may include a variety of complex features such as reducing sampling plans and using statistics to reduce the issues coming across.

• Ensures personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.

• Selects the required equipment for the product Quality Assurance activities and ensures that such equipment meets health, safety and environmental standards set by the company.

• Acts as validation assessor for multiple manufacturing processes under the areas of expertise.

• Participates in design reviews and validation efforts for processes at sustaining stage or sound start-up of new processes.

• Develops validation protocols and reports for process and test method validation efforts and strategies.

• Approves validation documentation.

• Drives documentation and process changes.

• Technically supervises or coordinates the work of engineers, draftspersons, technicians, and others who assist in specific assignments.

• Practices company safety, quality policies and procedures, actively requires conformance.

• Aligns criteria on the manufacturing lines and on validation efforts for f the transferred product lines.

• Conducts internal and supplier audits as required.

• Responds to complaints from customers and investigating the root cause.

• Ensures non-conforming product is segregated and disposed as per internal procedures.

• Leads Risk Management plans (pfmea) development.

• Leads and conducts CAPA for process and Quality System improvement.

• Acts as Quality Manager as required.

• Executes other activities designed by the Quality Manager as required.

• Leads team efforts to achieve departmental and company goals.