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 <ul> <li>Develop, apply, and maintain quality standards and protocols for materials and products at various stages of production.</li> <li>Collaborate with engineering and manufacturing teams to ensure quality standards are established and maintained.</li> <li>Conduct compliant validation processes for equipment, manufacturing processes, and quality information technology systems, including URS, FAT, IQ, OQ, PQ, and TMV.</li> <li>Review and approve validation test plans, reports, and deviations; perform statistical analysis to support validations and product release.</li> <li>Devise and implement inspection and testing methods, procedures, and equipment to ensure product accuracy and compliance.</li> <li>Investigate manufacturing events, defects, and rejects; analyze trends and recommend corrective and preventive actions (CAPA).</li> <li>Lead complaint-handling activities in collaboration with operating unit members.</li> <li>Maintain validation and quality documentation in compliance with applicable federal and international medical device regulations.</li> <li>Perform system administration and configuration of quality information technology systems.</li> <li>Prepare and maintain standard operating procedures (SOPs) for quality systems.</li> <li>Verify and document the effectiveness of CAPA and non-conformance resolutions.</li> <li>Coordinate with domestic and global stakeholders for compliance and quality improvement initiatives.</li> <li>Report on validation activities to fulfill regulatory requirements.</li> </ul> Minimum Requirements <ul> <li>Bachelor’s degree in Engineering (completed) + minimum 3 years of experience in a regulated industry (medical device, pharmaceutical, or related manufacturing).</li> <li>or Master´s degree in Engineering + 1-2 years of direct related experience.</li> <li>Experience with risk management documentation (pFMEAs).</li> <li>Experience in process validation and equipment qualification (excluding cleaning processes).</li> <li>Knowledge of URS, FAT, IQ, OQ, PQ, and TMV documentation (non-laboratory).</li> <li>Basic to intermediate statistical analysis skills, preferably with Minitab.</li> <li>Knowledge of defining validation strategies from design to manufacturing.</li> <li>Knowledge of Good Manufacturing Practices (GMP) and medical device regulations.</li> <li>Bilingual (English & Spanish – oral and written).</li> <li>Willingness to work 100% on-site.</li> </ul> Preferred Qualifications (Nice to Have) <ul> <li>Experience with design transfer activities and new product introduction projects.</li> <li>Experience investigating manufacturing events and supporting product disposition.</li> <li>Lean Six Sigma Green Belt Certification.</li> <li>Experience in defect/reject trend analysis.</li> <li>Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint, Outlook, Project).</li> <li>Familiarity with systems such as SAP, Agile, Compliance Wire, Maximo, MRO Program, TEDS, HR – ABRA Suite, Gallup Online Tool.</li> <li>Strong problem-solving and collaboration skills.</li> <li>Availability to work overtime and weekends when necessary.</li> </ul> Work Methodology: <ul> <li>Full time contract</li> <li>100% on-site job in Medtronic-Villalba, PR</li> <li>6 months of first contract with potential extensions based on performance and budget availability</li> <li>Administrative shift with availability to work non administrative hours or weekends</li> </ul>

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