Quality Engineer

Quality Engineer

Heredia, Costa Rica

Essential Duties and Responsibilities:

1. Provide quality support to assigned product development teams, ensuring products conform to quality standards, specifications, customer expectations, and regulations (e.g., FDA, ISO, MDI).
2. Conduct non-conforming product reviews, root cause analysis, and implement effective corrective actions.
3. Develop and monitor metrics related to quality system processes, driving improvements in these areas.
4. Initiate, review, and approve document change controls.
5. Manage Corrective and Preventive Actions (CAPA).
6. Perform internal audits of the Quality Management System (QMS) and provide guidance based on audit outcomes.
7. Conduct supplier audits and manage supplier-related quality issues, including corrective action responses.
8. Collaborate with suppliers and customers to resolve product quality issues and implement quality improvement programs.
9. Analyze QMS data for management reviews and verify quality records related to assigned production areas (e.g., batch documentation, calibration, incoming and finished goods inspection).
10. Provide functional input into risk management processes, including FMEA development.
11. Develop risk-based product and process validation protocols for new and existing products/processes.
12. Offer guidance on equipment calibration procedures and inspection/test methods.
13. Analyze inspection data and implement a ship-to-stock program for relevant incoming components.
14. Assist with manufacturing transfers between sites.
15. Travel as required.

Qualification Requirements:

• Bachelor’s degree in a science-related discipline or equivalent.
• 3+ years of relevant experience in a medical device-related quality function.
• QMS Auditor Certification is desirable.
• Fully bilingual in English and Spanish.
• Knowledge of FDA 21 CFR, ISO 13485, ISO 14971, MDI, etc.
• Experience in the use and application of statistical tools.
• Desired experience in internal and supplier auditing.
• Experience in facilitating external audits (e.g., NSAI, FDA).
• Instrument calibration knowledge.
• Proficiency with MS Project, MS Visio, Minitab, etc.
• Familiarity with measuring hand tools.

Technical Skills:

• Expertise in product and process validation, including FMEA, DOE, test method validation, and sampling plan analysis.
• Proficient in risk management for medical devices and associated tools.
• Experience with Six Sigma problem-solving methodologies and process improvement.
• Knowledge in change control and CAPA/non-conformance reports.
• Strong technical writing skills.

Key Attributes:

• Excellent verbal and written communication skills.
• Ethical and professional demeanor.
• Ability to learn quickly and adapt to changing priorities.
• Open to feedback and responsive to challenges.
• Strong organizational skills; manages tasks to meet timelines for internal and external customers.
• Results-oriented; accountable for assigned tasks.
• A motivated team player; fosters effective collaboration.