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$30 per hour
...manufacturing. Strong working knowledge of FDA Quality System Regulation (21 CFR Part 820), Good Manufacturing Practices (GMP), and ISO 13485. Hands-on experience with risk management tools (FMEA), process monitoring, CAPA, and root cause analysis. Experience...SuggestedHourly payBest Project Solutions
Puerto Rico16 days ago- ...communicate and conduct business more effectively in a global marketplace. Equipped with a quality management system certified to both the ISO 9001:2008 and EN 15038:2006 standards, TransPerfect provides a full array of language and business support services, including...SuggestedFull timeTemporary workInternshipLocal areaFlexible hours
TransPerfect
Puerto Rico12 days ago - ...communicate and conduct business more effectively in a global marketplace. Equipped with a quality management system certified to both the ISO 9001:2008 and EN 15038:2006 standards, TransPerfect provides a full array of language and business support services, including...SuggestedFull timeTemporary workInternshipLocal areaFlexible hours
TransPerfect
Puerto Rico29 days ago $60k
...management (IAM), and network security. Ensure compliance with applicable financial and data protection regulations (e.g., SOC 2, ISO 27001, PCI-DSS, GDPR, and other regulatory requirements). Monitor system performance, availability, capacity, and reliability....SuggestedZenus Bank
Puerto Rico24 days ago- ...diagnostics, or similar). • Strong knowledge of FDA Quality System Regulation (21 CFR Part 820), Good Manufacturing Practices (GMP), and ISO 13485. • Experience supporting new product introductions (NPI/NPD), including process development, equipment qualification, and...SuggestedContract work
Pinnaql
Puerto Rico17 days ago - ...manufacturing. Strong working knowledge of FDA Quality System Regulation (21 CFR Part 820), Good Manufacturing Practices (GMP), and ISO 13485. Hands-on experience with risk management tools (FMEA), process monitoring, CAPA, and root cause analysis. Experience...SuggestedWeekend work
Validation & Engineering Group, Inc
Puerto Rico17 days ago - ..., pharmaceuticals, diagnostics, biotechnology). • Strong working knowledge of pertinent regulations like 21 CFR Part 820, GMP, and ISO 13485. • Electrical and mechanical engineering background applied to automated manufacturing systems. • Experience with automation...Suggested
Validation & Engineering Group, Inc
Puerto Rico12 days ago - ...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
Biosimilar Sciences PR LLC
Puerto Rico2 days ago - ...Skills: Working knowledge of US FDA and International regulations governing the medical device industry, i.e., QSR, GMP, MDR, and ISO 13485. Knowledge of fundamental quality systems principles Knowledge in Qualification / Validation (IQ/OQ/PQ), Packaging Validation...SuggestedWork at office
Validation & Engineering Group, Inc
Puerto Rico27 days ago - ...experience in Process Validation, Equipment Qualification, and Computer System Validation (CSV) in compliance with FDA 21 CFR Part 820, ISO 13485, and cGMP requirements. Development and execution of Supplier Qualification, including technical audits, process capability...SuggestedWeekend work
Validation & Engineering Group, Inc
Puerto Rico11 days ago - ...highest ethics standards for the following position: Commissioning & Qualification (C&Q) Services For: Class 5 Manufacturing Rooms. .ISO 14644 testing For: Utilities and Facilities Qualifications To Do: C&Q Plan, Risk Assessments, Traceability Matrices, DQ/IQ/OQ/...SuggestedWeekend work
Validation & Engineering Group, Inc
Puerto Rico3 days ago - ...requirements, OSHA regulations, and established quality procedures. Maintain a clean, organized, and safe work environment. Comply with ISO, GMP, and GDP standards, required training, and audit processes. Adhere to NFPA 70E electrical safety standards. Be available...SuggestedHourly payFull time
- ...Environmental, Health and Safety (EHS): Comply with the requirements established in the Environmental Health and Safety (EHS) Program and the ISO 14001 Standard, including: ~ Complies with EHS trainings, policies and procedures. Maintains a safe area and work environment...SuggestedSummer workLocal areaImmediate startFlexible hoursShift workNight shift
- ...Product Introductions (NPI) and/or product transfers . Strong knowledge of FDA Quality System Regulation (21 CFR Part 820), GMP, and ISO 13485 . Hands-on experience with FMEA, CAPA, root cause analysis, and process monitoring systems . Experience collaborating...SuggestedContract workTemporary work
- ...Strong knowledge of network security and protocols Experience with IDS/IPS, firewalls, endpoint security Familiarity with NIST, ISO 27001 frameworks Scripting skills (Python, Bash) Preferred / Rare Skills Threat Hunting using MITRE ATT&CK framework...Suggested
- ...operational best practices, incident and problem management processes Awareness of compliance, regulatory, and security standards (ISO, SOC, GDPR) Excellent verbal and written communication skills for both technical and non technical audiences Strong...Local area
- ...Knowledge of ITIL practices including incident and problem management. Understanding of compliance and regulatory standards such as ISO, SOC, and GDPR. Familiarity with Agile and DevOps methodologies for infrastructure teams. Soft Skills Strong...Local area
$12.69 - $17.79 per hour
...Knowledge of principles of records and information management and governmental record keeping requirements. Knowledge of GMP's, FDA, ISO Standard and regulations. Good communication and writing skills. Ability to read and interpret drawings and production...Hourly payTemporary workWorldwide$51k - $71k
...manufacture and distribution of medical products is in compliance with corporate policies, U.S. Food and Drug Administration regulations, ISO, the Medical Device Directive and other applicable regulatory agencies. ESSENTIAL DUTIES AND RESPONSIBILITIES 1. Support...Temporary workWorldwide- ...artifacts. Maintain version-controlled repositories for scripts and automation frameworks. Validate automation against SOX/ISO controls and enforce segregation of duties. Performance & Optimization Automate capacity checks and performance tuning tasks...Remote work
$109.25k - $149.5k
...Chemical) • 8 years of experience of working within a medical device or other regulated industry with knowledge of Risk Management (ISO 14971 2019), EU MDR, MDD (Medical Device Directive), IEC 62366, ISO 13485 (Quality Management Systems), FDA QSR and cGMP. • Strong...Temporary workWorldwide
