Quality Assurance Engineer II

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 a Quality Assurance Engineer II to join our team in Costa Rica. 

SUMMARY:  

Ensure that compliance to customer, risk management, quality and design control requirements is demonstrated in design and development projects.  Help to ensure successful transfer of the design to manufacturing.   

Work on problems and projects of moderate scope where analysis of situation or data requires a review of identifiable factors. Participate in decisions on scope of work, selection of equipment and length of tasks. Decide on design changes to meet revised specifications. Provide and develop 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 as part of cross-functional team for developing, applying, revising and maintaining quality standards for designing and processing materials/products into partially or finished medical device products.    

• Helps design and implement methods and/or procedures for inspecting, testing and evaluating the precision and accuracy of products and/or production equipment. 

• Participates in performing design reviews and pre-validation assessments to ensure the processes have adequate and appropriate process controls.    

• Supports and helps develop validation strategy for new product/process transfers into manufacturing. 

• Supports generating and maintaining risk management files supporting product development projects, including Risk Management Plans/Reports, Hazard Analyses, FMEAs, Design Trace Matrices, Post Market Surveillance plans and other related documents based on translation of customer product requirements. 

• Supports generating reports for topics involving statistical analysis, including sample size requirements, process capability analysis, regression analysis, tolerance Interval Analysis and ANOVA.  

• Supports Product/ Process Development Engineering in Optimization activities which may include Design of Experiments of various process parameters and analyzing data.    

• Supports creation of Process Validation Protocols, analyzes data and supported creation of Process Validation Reports.    

• Interfaces with Customer as needed on Design and Development Responsibilities, Quality Issues and or Supplier Initiated Change Requests.    

• 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. 

• May technically supervise or coordinate the work of draftspersons, technicians, and others who assist in specific assignments. 

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

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

• May require conducting internal and supplier audits. 

• Migrate and integrate Quality Systems between transfers. 

• Support internal and external audits as required. 

• 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. 

• Work requires some basic knowledge of precedents, principles and practices in the product development and design assurance areas. Familiarity with regulatory guidance documents and standards is a bonus. 

• 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