Senior Quality & Reliability Engineer

For more than 80 years, our client’s engineers and product specialists have partnered with customers to produce highly engineered connectivity and sensing solutions that make a connected world possible. Their focus on reliability, durability, and sustainability exemplifies their commitment to progress. The unmatched range of their product portfolio enables companies, large and small, to turn ideas into technology that can transform how the world works and lives tomorrow.

Responsibilities:

Quality System & Compliance

• Develop and implement quality and reliability processes to support NPI.
• Lead the development and scaling of the site Quality Management System (QMS).
• Ensure QMS elements (management reviews, internal audits, supplier management) comply with global standards.
• Act as Lead Auditor for internal audits and ensure compliance with ISO 13485 and FDA QSR.
• Support external audits, including preparation, mock audits, and corrective actions.
• Review and approve ECOs, DCOs, training matrices, and other NPI documentation.
• Maintain updated quality policies and procedures aligned with evolving standards.

NPI Planning & Execution

• Represent Quality in customer meetings and business reviews.
• Collaborate with cross-functional teams including engineering, manufacturing, PMO, and supply chain.
• Support implementation of electronic quality systems for improved traceability and documentation.
• Evaluate product development objectives to identify quality improvement opportunities.
• Create, review, and maintain quality system documents specific to NPI.
• Calculate and present NPI quality KPIs.

Continuous Improvement & Problem Solving

• Lead or support quality system improvement projects.
• Use statistical and scientific methods to analyze data and drive improvements.
• Provide expertise in CAPA, root cause analysis, and reliability engineering tools.
• Facilitate cross-functional improvement teams focused on NPI processes.

Training & Leadership

• Conduct training in GDP, GMP, CAPA, and compliance topics.
• Oversee CAPA investigations to ensure true root cause identification and effective corrective actions.
• Supervise and mentor Quality Engineers supporting NPI initiatives.

Requirements:

Required Skills & Competencies

Core Competencies

• Strong technical learning ability
• Excellent problem-solving and analytical thinking
• High ethical standards and integrity
• Action-oriented and self-driven

Job-Specific Skills

• Knowledge of NCMRs, CARs, CAPA, customer complaints, RMA metrics, DPPM, and DLPM
• Strong technical "hands-on" skills
• Excellent communication and interpersonal abilities
• Ability to manage multiple tasks in a fast-paced environment
• Strong prioritization and organizational skills
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Visio)
• Advanced technical report writing skills
• Strong understanding of ISO 13485 and FDA QSR
• Bilingual English (Advanced) / Spanish preferred
• Willingness to travel up to 20% (based in Costa Rica)

Experience & Education

• Experience: 5+ years of Quality leadership experience in a manufacturing environment, preferably in multinational settings and NPI roles.
• Education: Bachelor’s degree in a scientific or engineering discipline.
• Certifications: CQE/CSSBB certification preferred.