Quality Engineer Staff

at  Confluent Medical Technologies

Job Description:
Confluent Medical Technologies is dedicated to working collaboratively with our customers, taking their projects from rapid prototype into high volume production. Our unparalleled technical expertise, proven experience and partnership with our clients has allowed us to perfect the process necessary to deliver world-class medical devices through innovative material science, engineering, and manufacturing. Our primary capabilities include: Nitinol components, balloon expandable stents and balloon catheters, delivery systems, biomedical textiles, access kits, and guidewires. We take pride in our position as the leader in the medical technology space and are driven by a passion to create products that our clients have envisioned for their customers.
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 II 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 on problems and projects of moderate 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. Decides on design changes to meet revised specifications. Provides and develops solutions to problems of limited scope. Must be able to accomplish broad assignments. May provide technical guidance to lower level personnel.

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

• Responsible for developing, applying, revising and maintaining quality standards for processing materials/products into partially or finished products.
• Helps design 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.
• Respond 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.
• Respond 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 medium complexity 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 scope.
• Performs work which involves conventional engineering practice but may include a variety of medium complexity features.
• Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
• Responsible for the purchase of equipment that meets health, safety and environmental standards set by the company.
• Responsible for performing design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes.
• May technically supervise or coordinate the work of draftspersons, technicians, and others who assist in specific assignments.
• Practices company safety, quality policies and procedures, actively requires conformance.
• May require conducting internal and supplier audits.
• Responding to complaints from customers and investigating the root cause.
• Migrate and integrate Quality Systems between transfer.
• Lead validation strategy for transfers.
• Support internal and external audits, war room others.
• Comply with all safety policies, practices and procedures. Report all unsafe activities to supervisor and/or Human Resources.
• Participate in proactive team efforts to achieve departmental and company goals.
• Perform other duties as assigned.

EDUCATION and/or EXPERIENCE: bachelor´s degree in a related engineering discipline; 2-3 years of related experience. Proficient oral and written English level. Experience in the medical device industry would be an asset. Certification and/or license in specific discipline would be an asset. Certified Quality Engineer would be an asset. Training as Internal Auditor in ISO 9001, 13485 or Biomedical field would be an asset.
COMMENTS: This position description is an outline of the major recurring responsibilities of the job. It is not intended to be all-inclusive of the work to be performed. The incumbent(s) will typically perform other related job objectives, special assignments and less significant responsibilities

• Responsible for developing, applying, revising and maintaining quality standards for processing materials/products into partially or finished products.
• Helps design 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.
• Respond 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.
• Respond 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 medium complexity 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 scope.
• Performs work which involves conventional engineering practice but may include a variety of medium complexity features.
• Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
• Responsible for the purchase of equipment that meets health, safety and environmental standards set by the company.
• Responsible for performing design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes.
• May technically supervise or coordinate the work of draftspersons, technicians, and others who assist in specific assignments.
• Practices company safety, quality policies and procedures, actively requires conformance.
• May require conducting internal and supplier audits.
• Responding to complaints from customers and investigating the root cause.
• Migrate and integrate Quality Systems between transfer.
• Lead validation strategy for transfers.
• Support internal and external audits, war room others.
• Comply with all safety policies, practices and procedures. Report all unsafe activities to supervisor and/or Human Resources.
• Participate in proactive team efforts to achieve departmental and company goals.
• Perform other duties as assigned