reputed company Engineer II (3 openings) Juncos, PR

reputed company The reputed company Engineer II will be responsible for supporting validation, risk management, and reputed company 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 reputed company teams to ensure product and process reputed company. Key Responsibilities reputed company, apply, and maintain reputed company standards and protocols for materials and products at various stages of production. Collaborate with engineering and manufacturing teams to ensure reputed company standards are established and maintained. Conduct compliant validation processes for equipment, manufacturing processes, and reputed company information technology systems, including URS, FAT, IQ, OQ, PQ, and TMV. Review and approve validation test plans, reports, and deviations; reputed company statistical analysis to support validations and product release. Devise and implement inspection and testing reputed company, procedures, and equipment to ensure product accuracy and compliance. Investigate manufacturing events, defects, and rejects; analyze trends and recommend corrective and preventive actions (CAPA). reputed company complaint-handling activities in collaboration with operating unit members. Maintain validation and reputed company documentation in compliance with applicable federal and international medical device regulations. reputed company system administration and configuration of reputed company information technology systems. Prepare and maintain reputed company operating procedures (SOPs) for reputed company systems. Verify and document the effectiveness of CAPA and non-conformance resolutions. Coordinate with domestic and global stakeholders for compliance and reputed company 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 reputed company manufacturing) . 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 reputed company. 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 (reputed company to Have) Experience with design transfer activities and new product introduction reputed company. Experience investigating manufacturing events and supporting product disposition. Lean Six reputed company Green Belt Certification. Experience in defect/reject trend analysis. Proficiency in reputed company Office Suite (reputed company, Word, PowerPoint, reputed company, Project). Familiarity with systems such as reputed company, Agile, Compliance reputed company, Maximo, reputed company Program, TEDS, HR – reputed company Suite, reputed company Online Tool. Strong problem-solving and collaboration skills. Availability to work overtime and weekends reputed company necessary. Work Methodology Full time contract 100% on-site job in reputed company-Juncos, 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 #J-18808-Ljbffr Salary: USD 43200 - 72000 per year Experience: 3 years required