Quality Assurance Engineer I

Overview

In this role, you will play a vital part in ensuring that the medical devices we manufacture meet the highest standards of safety, quality, and efficacy. Operating within our Alajuela facility, you will support production lines, resolve quality challenges in real-time, and ensure compliance with global regulatory standards. This position exists to bridge the gap between technical engineering requirements and shop-floor execution.

If you are an early-career engineer looking to build a deep, hands-on foundation in medical device quality systems within a collaborative and growth-oriented environment, this role offers the perfect platform to advance your career while making a direct impact on patient lives.

What Success Looks Like

Success in this role means being a proactive, visible partner on the manufacturing floor. You will build strong relationships with production operators and process engineers to keep assembly lines running safely and compliantly.

Day-to-Day Responsibilities

• Monitor manufacturing lines to ensure compliance with quality standards, standard operating procedures, and product specifications.
• Investigate non-conformances (NCRs), perform structured root-cause analysis, and document findings clearly and accurately.
• Review production records and documentation to ensure complete traceability and regulatory compliance.
• Collaborate with manufacturing teams to quickly address and resolve quality issues on the production floor.

Long-Term Impact

• Participate in and support equipment and process validations (IQ/OQ/PQ) as production lines scale or transfer.
• Identify trends in quality data and help lead small-scale continuous improvement projects to reduce defect rates.
• Support the site during internal and external regulatory audits, acting as a subject matter expert for your assigned manufacturing areas.

Qualifications

We are looking for a methodical, detail-oriented professional who thrives in a collaborative team environment. We have separated our requirements into what is essential to start and what can be learned on the job.

Must-Have Requirements

• Education: Bachelor’s degree in Industrial, Mechanical, Chemical, Biomedical Engineering, or a closely related technical field.
• Experience: 1 to 3 years of experience in a quality assurance or quality engineering role within a manufacturing environment.
• Language Skills: Professional working proficiency in both English and Spanish (written and verbal) to effectively collaborate with local and global teams.
• Problem-Solving: Basic understanding of root cause analysis tools (such as Ishikawa diagrams, 5 Whys, or FMEA).
• Attention to Detail: Strong documentation practices and the ability to review technical data with high precision.

Nice-to-Have Skills

• Prior experience working within a regulated industry, such as medical devices, pharmaceuticals, or aerospace.
• Familiarity with ISO 13485 or FDA 21 CFR Part 820 standards.
• Basic proficiency with statistical software (such as Minitab) and statistical process control (SPC).

Join Our Team

If you are ready to apply your engineering skills to meaningful work that directly improves global healthcare, we encourage you to apply. Please submit your resume to begin the conversation with our team.