Summary
The Quality Engineer II will be responsible for supporting validation, risk management, and quality assurance activities in a regulated medical device manufacturing environment. This role requires expertise in validation protocols, statistical analysis, and regulatory compliance, with the ability to work cross-functionally with engineering, manufacturing, and quality teams to ensure product and process excellence.

Key Responsibilities

• Develop, apply, and maintain quality standards and protocols for materials and products at various stages of production.
• Collaborate with engineering and manufacturing teams to ensure quality standards are established and maintained.
• Conduct compliant validation processes for equipment, manufacturing processes, and quality information technology systems, including URS, FAT, IQ, OQ, PQ, and TMV.
• Review and approve validation test plans, reports, and deviations; perform statistical analysis to support validations and product release.
• Devise and implement inspection and testing methods, procedures, and equipment to ensure product accuracy and compliance.
• Investigate manufacturing events, defects, and rejects; analyze trends and recommend corrective and preventive actions (CAPA).
• Lead complaint-handling activities in collaboration with operating unit members.
• Maintain validation and quality documentation in compliance with applicable federal and international medical device regulations.
• Perform system administration and configuration of quality information technology systems.
• Prepare and maintain standard operating procedures (SOPs) for quality systems.
• Verify and document the effectiveness of CAPA and non-conformance resolutions.
• Coordinate with domestic and global stakeholders for compliance and quality improvement initiatives.
• Report on validation activities to fulfill regulatory requirements.

Minimum Requirements

• Bachelor’s degree in  Engineering (completed) + minimum 3 years of experience in a regulated industry (medical device, pharmaceutical, or related manufacturing).
• or Master´s degree in Engineering + 1-2 years of direct related experience.
• Experience with risk management documentation (pFMEAs).
• Experience in process validation and equipment qualification (excluding cleaning processes).
• Knowledge of URS, FAT, IQ, OQ, PQ, and TMV documentation (non-laboratory).
• Basic to intermediate statistical analysis skills, preferably with Minitab.
• Knowledge of defining validation strategies from design to manufacturing.
• Knowledge of Good Manufacturing Practices (GMP) and medical device regulations.
• Bilingual (English & Spanish – oral and written).
• Willingness to work 100% on-site.

Preferred Qualifications (Nice to Have)

• Experience with design transfer activities and new product introduction projects.
• Experience investigating manufacturing events and supporting product disposition.
• Lean Six Sigma Green Belt Certification.
• Experience in defect/reject trend analysis.
• Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint, Outlook, Project).
• Familiarity with systems such as SAP, Agile, Compliance Wire, Maximo, MRO Program, TEDS, HR – ABRA Suite, Gallup Online Tool.
• Strong problem-solving and collaboration skills.
• Availability to work overtime and weekends when necessary.

Work Methodology:

• Full time contract
• 100% on-site job in Medtronic-Villalba, PR
• 6 months of first contract with potential extensions based on performance and budget availability
• Administrative shift with availability to work non administrative hours or weekends