Quality Assurance Engineer I

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 I to join our team in Costa Rica.

The Quality Assurance Engineer is responsible for developing, implementing, and continuously improving quality systems and standards to ensure compliance with regulatory requirements and company policies.

Key responsibilities include:

• Develop, maintain, and improve quality standards, inspection methods, testing procedures, and documentation for products and manufacturing processes.

• Analyze quality data, customer complaints, nonconformances, and returned products to identify root causes and implement effective corrective and preventive actions.

• Manage supplier quality activities, including reviewing supplier corrective action responses (SCARs) and determining when supplier actions are required.

• Plan, coordinate, and execute quality engineering projects, applying sound engineering judgment and adapting standard techniques to resolve complex issues.

• Support product transfers by leading quality system migration, integration activities, and validation strategies to ensure seamless implementation.

• Conduct design reviews and pre-validation assessments to ensure new processes meet quality, safety, and environmental requirements.

• Support internal, supplier, customer, and regulatory audits, including audit preparation and war room activities.

• Collaborate with cross-functional teams to investigate quality issues, drive continuous improvement initiatives, and ensure compliance with health, safety, environmental, and quality policies.

• Provide technical guidance to technicians and other team members and coordinate quality-related activities as needed.

• Ensure compliance with all applicable federal, state, local, and company regulations while promoting a culture of quality, safety, and operational excellence.

EDUCATION and/or EXPERIENCE:

• Bachelor's degree in a related engineering discipline

• Minimum 1 year of related work experience

• Proficient oral and written English level.

• Knowledge of statistics and Minitab is a must.

Preferred:

• Experience in the medical device industry

• Certification and/or license in specific discipline

• Certified Quality Engineer

• Training as Internal Auditor in ISO 9001, 13485 or Biomedical field

Other Skills and Competencies:

• Strong customer service orientation with a commitment to quality, accuracy, and confidentiality.

• Excellent analytical, problem-solving, multitasking, and project management skills.

• Ability to read, analyze, interpret, and apply technical documentation, specifications, and procedures.

• Effective written and verbal communication skills, with the ability to present complex information clearly to cross-functional teams and stakeholders.

• Ability to identify issues, collect and analyze data, draw sound conclusions, and develop practical solutions.

• Capable of interpreting technical instructions, diagrams, and mathematical information while managing multiple variables in a dynamic manufacturing environment.