Quality Assurance Engineer I

Job Description:

Confluent Medical Technologies is a financially healthy and rapidly growing medical device company 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 and tubing, balloon expandable stents and catheters, complex catheters, biomedical textiles, and high precision polymer tubing. 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 selected candidate will work on problems and projects of moderate scope, applying analytical skills to evaluate situations and data and identify relevant factors. Participate in decisions regarding the scope of work, equipment selection, and task timelines. Evaluate and implement design changes to meet revised specifications and requirements. Develop and recommend solutions to problems of limited scope while ensuring compliance with applicable quality standards and procedures. Demonstrate the ability to manage and successfully complete assignments of broad scope. May provide technical guidance and support to lower-level personnel and cross-functional team members.

Shift available: Compressed Day Shift Sunday - Wednesday (6am - 6pm)

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

• Develop, implement, revise, and maintain quality standards for materials, components, and finished products.

• Develop and implement inspection, testing, and evaluation methods to ensure product and equipment quality, precision, and accuracy.

• Analyze quality reports, customer complaints, returned products, and nonconformances to identify root causes and recommend corrective actions.

• Manage supplier quality issues, including reviewing Supplier Corrective Action Responses (SCARs) and determining when supplier SCARs are required.

• Prepare and maintain documentation for inspection, testing, validation, and quality procedures.

• Independently evaluate quality issues, apply sound engineering judgment, and develop solutions using standard and modified engineering techniques.

• Plan and coordinate quality engineering activities for small-scope projects or assigned phases of larger projects.

• Support process transfers by integrating quality systems and leading validation strategies to ensure compliance with applicable requirements.

• Support internal, supplier, and external audits, including audit preparation and resolution of findings.

• Conduct internal and supplier audits, as assigned.

• Respond to customer and regulatory inquiries and complaints and support root-cause investigations and corrective actions.

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

• Provide technical guidance and coordination to technicians and other personnel supporting quality activities.

• Ensure compliance with company policies and applicable federal, state, local, health, safety, environmental, and quality regulations.

• Support a culture of safety and quality by actively promoting compliance with established policies, practices, and procedures.

• Participate in cross-functional initiatives and 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 (completed

• minimum of 1 year of relevant experience; experience in the medical device industry is a plus.

• Medium oral and written English level (B1/B2)

• Certified Quality Engineer (CQE) certification is a plus.

• Training or certification as an Internal Auditor in ISO 9001, ISO 13485, or a biomedical-related field is a plus.

OTHER SKILLS and ABILITIES:  

• Basic knowledge of engineering principles, quality systems, and industry practices.
• Knowledge of statistics and Minitab is a plus.
• Strong analytical, problem-solving, documentation, and project management skills.
• Customer-focused with strong attention to quality, confidentiality, and accuracy.
• Ability to analyze technical information, identify problems, collect and interpret data, establish facts, and develop sound conclusions.
• Ability to read and interpret technical documents, procedures, diagrams, and mathematical information.
• Strong communication and presentation skills, with the ability to effectively communicate with cross-functional teams and stakeholders.
• Ability to manage multiple priorities and work independently with appropriate guidance.
• Proficient in Microsoft Office and standard computer applications, including email, word processing, spreadsheets, databases, and presentations.

ENVIRONMENTAL WORKING CONDITIONS

Well-lighted, heated and/or air-conditioned indoor office setting with adequate ventilation.

PHYSICAL DEMANDS

Other physical working conditions:     

Lifting or carrying items.

Moderate noise (examples: business office with computers and printers, light traffic)

PHYSICAL ACTIVITY LEVEL: Moderate physical activity moving around the manufacturing process and offices areas, as well as performing somewhat strenuous daily activities of a primarily administrative nature.