Quality Assurance Engineer II - P22-003

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.
We are looking for an Quality Assurance Engineer II to join our team in Costa Rica.
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.
• Knowledge of statistics and Minitab is a must.

OTHER SKILLS and ABILITIES:

• Experienced in managing non-conforming product processes
• Proficient in conducting complaint investigations
• Skilled in process validation
• Knowledgeable in process changes and impact assessments
• Competent in risk management

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