Quality Assurance Engineer II

About the role

Confluent Medical Technologies is seeking a Quality Assurance Engineer II to support the design and development of medical device products in Costa Rica. The role ensures compliance with customer, risk management, quality and design control requirements and assists in transferring designs to manufacturing.

Key responsibilities

• Develop, apply, revise and maintain quality standards for material and product design.
• Design and implement inspection, testing and evaluation methods for products and equipment.
• Participate in design reviews and pre‑validation assessments to verify process controls.
• Support validation strategy for new product and process transfers.
• Create and maintain risk management documentation, including risk plans, hazard analyses, FMEAs and design trace matrices.
• Perform statistical analyses such as sample size determination, capability studies, regression, tolerance intervals and ANOVA.
• Conduct Design of Experiments and analyze data to optimize processes.
• Develop process validation protocols, analyze results and prepare validation reports.
• Interface with customers on design, quality issues and change requests.

Required profile

• Experience in medical device quality assurance or related manufacturing environment.
• Ability to work on moderate‑scope projects, analyze data and provide technical guidance.
• Strong judgment in adapting standard techniques and devising new problem‑solving approaches.

Required skills

• Statistical analysis
• Design of Experiments
• Risk Management
• Failure Mode and Effects Analysis (FMEA)
• Process Validation
• Design review participation
• Validation protocol development