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- ...required by Finance. Take appropriate action to resolve data and/or inventory issues as needed. Complies with all GMP, regulatory and ISO guidelines including company policies and departmental procedures. Participates as required in training on regulatory issues...SuggestedFull timeWork at officeWorldwideShift work
- ...and Supply Chain teams to resolve quality issues and improve manufacturing processes. Ensure compliance with safety policies, GMP, ISO standards, and applicable regulations. Participate in continuous improvement initiatives using Lean Manufacturing and Six Sigma...SuggestedWork at office
SOLX HOLDINGS LLC
Puerto Rico2 days ago - ...punctuality norms. Maintain good work habits. Comply with the standards, practices, and regulations established by Quality, including ISO 9001; HSE, including ISO 14001; and Human Resources, the Employee Manual, the Attendance Policy, the Code of Conduct, among others....SuggestedLocal areaImmediate startMonday to Friday
- ...puntualidad. Mantener buenos hbitos de trabajo. Cumplir con las normas, prcticas y regulaciones establecidas por Calidad, incluyendo ISO 9001; HSE, incluyendo ISO 14001; y Recursos Humanos, el Manual del Empleado, la Poltica de Asistencia, el Cdigo de Conducta, entre...Suggested
- ...reglamentaciones y normas en materia de higiene, sanidad, etc. Apoyo con la documentación y cumplimiento con el estándar de calidad ISO 9001:2015. Proveer estatus y reportes, según solicitados, sobre el progreso de las actividades que este realizando. ~ Asistir...SuggestedFlexible hours
- ...material, leaflets, paperboard, sterile barrier packaging, corrugate, etc.). Familiar with distribution testing per ASTM D4169 and ASTM, ISO, TAPPI, USP and EP testing standards. Strong interpersonal, project management, technical problem solving and communication (...SuggestedFor contractorsLocal areaShift work
- ...with tool and machine design ~ Fluent in English and Spanish with strong written and oral communication ~ Knowledge of cGMP, OSHA, ISO 9000, and continuous improvement techniques ~ Expertise in packaging methods: heat sealing, thermoforming, thermoplastic ~ Strong...Suggested
- ...manufacturing facilities. The role reports to an Engineering Manager and drives continuous improvement initiatives while maintaining GMP and ISO compliance. Responsibilities Develop process excellence techniques and track efficiency improvement trends Lead moderate to...SuggestedWork at office
- ...cabo el desarrollo y las pruebas de nuevas arquitecturas de equipos. Coordina las pruebas de vulnerabilidad y de penetración de la ISO, identificando y defendiéndose contra las amenazas, y desarrollando planes de recuperación ante desastres. Ejecuta y supervisa las...Suggested
- ...Bachelor’s or Master’s degree in Mechanical, Industrial, Electrical Engineering, or related field preferred. Experience in FDA/ISO-regulated manufacturing environments, including GMP compliance, inspection readiness, ISO 13485, CAPA, nonconformance management, change...SuggestedLocal areaShift workDay shiftAfternoon shift
- ...design reviews, and oversee new equipment installations. --Ensure compliance with industry standards such as OSHA, API, ASME, and ISO. --Lead and mentor a multidisciplinary team focused on maintenance and reliability best practices. --Facilitate Process Hazard Analyses...Suggested
$81.65k - $112.7k
...2 years Strong knowledge of QSR, GMP, Design Controls, and Process Validation in medical device industry Proficiency with FDA, ISO, ASTM, and ISTA standards including ISO 11607, ISO 13485, and ISO 14971 Solid understanding of packaging materials, structures, components...SuggestedWork at office$81.65k - $112.7k
...experience Strong knowledge of QSR, GMP, Design Controls, and Process Validation in medical device industry Familiarity with FDA, ISO, ASTM, and ISTA requirements; ability to apply ISO 11607, ISO 13485, ISO 14971, and 21 CFR Part 820 Solid understanding of...Suggested- ...MSA, and process capability studies Experience leading equipment qualifications and validation activities (IQ/OQ/PQ) Knowledge of FDA QSR, ISO 13485, GMP, and quality system requirements Experience supporting nonconformance investigations and CAPA initiatives...Suggested
- ...cleanrooms. • Establish routine and non-routine cleaning schedules, procedures, and workflows for classified manufacturing areas (e.g., ISO 5–8). • Perform hands-on cleaning activities within cleanroom environments in accordance with cGMPs, SOPs, and aseptic practices....SuggestedLocal area
- ...Engineering ~3-5 years of engineering experience ~ Strong experience with IQ, OQ, and PQ validation protocols ~ Knowledge of cGMP, ISO standards, and regulated manufacturing ~ Bilingual proficiency in Spanish and English ~ Strong analytical and problem-solving...
$58.1k
...Responsibilities Maintain and report site EH&S metrics, statistics and records to maintain compliance with regulatory requirements, support the ISO 14001 EMS, and fulfill Corporate reporting and information needs. Support management of the Workers’ Compensation program, and pro...Hourly payLocal areaShift work- ...team of manufacturing engineers supporting operations, process improvement, equipment reliability, and validation in a regulated GMP/ISO environment. Interfaces across multiple functional areas to drive operational performance and business-critical initiatives. Responsibilities...
$166.75k - $228.85k
...implementation of procedures across manufacturing sites Represent microbiology in internal and external audits including FDA inspections and ISO certifications Create long-term strategies and provide leadership direction to ensure quality, compliance, and business objectives...$166.75k - $228.85k
...experience managing managers or large teams ~ Strong knowledge of Quality Management Systems and regulatory standards (FDA QSR/QMSR, ISO 13485, EU MDR, MDSAP) ~ Medical device industry experience with regulatory inspection and audit support ~ Proficiency in SQL and...$73k - $102k
...analysis software Financial acumen for budget management and continuous improvement ROI analysis Knowledge of GMP, FDA regulations, ISO 9001, and ISO 13485 standards Familiarity with health, safety, and environmental manufacturing regulations Compensation: $73,0...$16.83 - $23.56 per hour
...pneumatic systems, pumps, and motors Proficiency with preventive maintenance software such as Maximo or Oracle Bilingual communication ability in English and Spanish Familiarity with FDA, OSHA, EPA, and ISO regulations Compensation: $16.83 - $23.56 USD Hourly...Hourly payShift workNight shift$87k - $122k
...experience Strong written and oral English communication skills Financial acumen in operations P&L management Knowledge of FDA regulations, ISO 9001, ISO 13485, and EU MDR compliance Familiarity with lean six-sigma methodologies and continuous improvement tools...- ...ResponsibilitiesMaintain and report site EH&S metrics, statistics and records to maintain compliance with regulatory requirements, support the ISO 14001 EMS, and fulfill Corporate reporting and information needs.Support management of the Workers’ Compensation program, and pro-...Hourly payLocal areaShift work
Boston Scientific Corporation
Puerto Rico3 days ago - ...compromising product protection or quality.Documentation & Process DevelopmentDevelop and maintain packaging standards, specifications, and ISO-compliant process documentation.Create and maintain packaging design guidelines and qualification procedures.Communicate project...Full timeContract workWork at officeLocal areaImmediate startWorldwide2 days per week
Hewlett Packard Enterprise
Puerto Rico5 days ago - ...monitoring programs Strong data analysis and interpretation of microbiological and particulate monitoring trends Knowledge of ISO 14644, ISO 11137, ISO 11737, EN 17141 standards and quality systems including CAPA and deviation management Experience with endotoxin...
$81.65k - $112.7k
...complaint trending, signal detection, and root cause analysis ~ Strong knowledge of global medical device regulations (FDA, EU MDR, ISO 13485, ISO 14971, QMSR) ~ Proficiency with statistical software or data visualization tools (Minitab, Power BI, Oracle, TrackWise)...- ...risks, threats and prevention measures. Strong knowledge of cybersecurity and risk management frameworks such as NIST CSF, NIST 800-53, ISO 27001, and industry best practices.Knowledge and experience of security fundamentals and technologies.Experience translating...Full timeWork at officeLocal areaImmediate start2 days per week
Hewlett Packard Enterprise
Puerto Rico7 days ago - ...s platform architecture and cloud infrastructure (GCP). Ensure high availability, reliability, and audit‑ready compliance (SOC 2, ISO 27001). Partner with Product, Operations, and Compliance leaders to align technical solutions with client impact. Report directly...Full timeWork at officeLocal area
DECA
Puerto Rico2 days ago - ...security Data security Security architecture Third-party risk Business continuity/cyber resilience Familiarity with NIST, ISO 27001, CIS Controls, COBIT, or equivalent frameworks. Experience managing security teams and external security vendors. Strong...
thehivecareers.co
Puerto Rico3 days ago
