Sr. Quality Systems Engineer

Quality Systems Engineer III
Location: San Rafael, Alajuela, Costa Rica
Reports to: Quality Manager

About the Role:

As a Quality Systems Engineer III, you will act as a key Quality representative, driving awareness, visibility, and communication on quality initiatives and objectives. This role ensures compliance with Medical Device regulations and ATL Quality System requirements while fostering a continuous improvement mindset. You will lead quality assurance programs to maintain consistent production standards and regulatory compliance.

Key Responsibilities:

• Interpret and apply policies, regulatory requirements, and internal standards to ensure compliance.

• Communicate and document compliance-related updates, including regulatory changes and new guidelines.

• Develop and maintain quality programs, systems, and procedures aligned with internal and external standards.

• Lead audit and inspection preparation, manage findings, and liaise with auditors and inspectors.

• Apply systematic problem-solving methodologies to resolve quality issues.

• Participate in CAPA and Continuous Improvement projects.

• Build quality into all aspects of work by maintaining compliance with all quality requirements.

• Other duties as assigned.

Additional Focus Areas:

Business Improvement

• Lead or support quality improvement initiatives and benchmarking activities.

• Define quality metrics and align them with plant objectives.

• Review and approve Engineering Change Orders (ECOs).

Compliance & Regulatory

• Ensure compliance with QSRs, ISO 13485, and other applicable regulations.

• Lead regulatory audit preparation and responses.

• Maintain documentation of quality assurance activities and systems.

Product Quality & Performance

• Review and approve investigations, NCs, CAPAs, and customer complaints.

• Provide technical direction for complex manufacturing issues.

Leadership & People Development

• Mentor and coach team members, fostering a positive and inclusive culture.

• Drive talent strategy and succession planning.

Continuous Improvement & Collaboration

• Standardize and optimize Quality Systems processes.

• Develop strategic roadmaps for key QS functions (NC/CAPA, Change Control, Document Control, QMS).

• Build strong relationships across site and global functions.

What You Need:

Required:

• Bachelor's degree in Engineering, Sciences, or related field.

• 5+ years of experience in medical device manufacturing, quality, or regulatory/compliance.

• 3+ years of experience specifically in Quality Systems.

• Excellent communication skills in English and Spanish (spoken and written).

Preferred:

• Knowledge of ISO 13485, FDA 21 CFR Part 820, ISO 14971.

• Experience leading internal, external, and regulatory audits.

• Strong analytical and problem-solving skills with data-driven decision-making.

• Technical writing and documentation expertise.

• Project management skills and proficiency in computer applications.

• Certifications such as CQA, CQE, CQM, CBA, MBB, or BB are a plus.

Why Join Us?

• Opportunity to lead strategic quality initiatives in a global medical device organization.

• Collaborative and inclusive work environment.

• Professional growth and development opportunities.

About ATL Technology:
ATL Technology is a global leader in custom interconnect solutions, specializing in the design, development, and manufacturing of medical devices and components. With operations across North America, Europe, and Asia, ATL partners with leading OEMs to deliver innovative, high-quality solutions that improve patient outcomes. Our Costa Rica facility plays a key role in supporting global operations through advanced engineering, quality systems, and a commitment to continuous improvement.