Jobs at Quality Consulting Group

Lead and execute validation of quality IT systems and computer/software validation for medical devices. Coordinate with clients, developers, and operations; manage FCA/CAPA and process validation lifecycle (IQ/OQ/PQ); develop SOPs and change controls; report validation status and ensure compliance with FDA 21 CFR 820, ISO 13485, EU MDR; use QMS tools and DOE (Minitab) as needed.

Support manufacturing and quality systems including non-conformances, change controls, process validation, deviations/CAPA, risk and microbial assessments, MBR and BOM reviews, training, campaign readiness, and floor troubleshooting. Own investigations, write technical reports and protocols, and drive process improvements and procedure ownership to ensure compliant biopharma manufacturing operations.

Lead engineering projects to optimize processes, troubleshoot manufacturing equipment, and implement reliability and maintenance improvements. Develop policies, analyze performance metrics, guide CAPA and change control, supervise small engineering teams, and ensure regulatory, qualification, and EHS compliance in pharmaceutical/medical device manufacturing.

Manage operational aspects of product development projects from initiation through delivery. Oversee schedules, budgets, status reporting, and cross-functional teams; identify and resolve project issues; develop monitoring and intervention mechanisms to meet productivity, quality, and client-satisfaction goals.

Design and implement small-scale automated equipment: PLC programming, vision system and robot integration, CAD modeling and wiring schematics, SCADA/HMI development, and support compliance and vendor evaluation. Contribute to R&D and mentor junior staff while advancing automation technology from design to implementation.

Lead end-to-end MES program for a pharmaceutical/medical device manufacturing site: govern planning, delivery, integration (BPCS, SAP, Cornerstone, equipment), ensure compliance, minimize production disruption, manage budgets/schedules/resources/risks, drive go‑live, hypercare, training, change management, and continuous improvement.

Ensure suppliers deliver quality parts and services by qualifying and auditing suppliers, monitoring parts through manufacturing, supporting pre-market supplier quality for NPD, developing control plans and sampling strategies, defining receiving inspection and test method validation, and driving continuous improvement and regulatory compliance.

Develop and maintain quality standards and protocols for materials and products; design and conduct inspection, testing and statistical analysis; collaborate with engineering and manufacturing to implement corrective actions and ensure documentation compliance; may specialize in design, incoming material, production control, reliability, inventory, or R&D; work cross-functionally to improve manufacturing processes.

Manage full-cycle recruiting: source, screen, interview, and hire candidates; coordinate pre-employment checks; create onboarding and orientations; collaborate with hiring managers; run high-volume recruiting and attend job fairs across Puerto Rico.

Perform computer system validation (CSV) for FW Pulse computers, prepare/execute protocols and reports, ensure EC/EF/firmware parity, support FW Pulse projects and ancillary software, design manufacturing processes and layouts, and ensure regulatory compliance in manufacturing environments.

Designs and improves manufacturing processes, production layouts, and equipment arrangements for pharmaceutical/medical device production. Performs equipment inspections, develops process controls (including SPC), leads investigations and root-cause analysis, and provides technical/sustaining engineering support to ensure product quality and validation compliance.

Provide engineering support to medical device production lines: troubleshoot process deviations and equipment, monitor performance metrics, lead continuous improvement and Lean/Six Sigma initiatives, analyze process data for root causes, support production shifts, and manage product and equipment investigations to minimize downtime and improve yield.

Design and validate manufacturing processes, equipment IQ, and computer software; layout production lines; inspect machinery; perform root-cause investigations; develop statistical process control methods to ensure product quality and continuous improvement.

Lead engineering efforts for process optimization, troubleshooting, and system/facility modifications in pharmaceutical manufacturing. Coordinate cross-functional teams, manage consultants and budgets, develop policies and protocols, and supervise engineers/technicians. Apply advanced engineering techniques, validation/documentation, and inspection technology expertise for parenteral and glass container equipment.

Design, develop, and implement small-scale automated equipment and systems for manufacturing. Work on PLC programming, vision system and robot integration, CAD models and wiring schematics, SCADA/HMI development, and ensure safety and quality compliance. Support R&D and project delivery, mentor junior staff, and evaluate vendor capabilities.

Support manufacturing process and equipment validation (PV: characterization, OQ, PQ) and equipment qualification (CSV: URS, FAT, IQ, OQ, PQ, TMV). Provide sustaining engineering, recommend and implement process/equipment modifications to improve yields and efficiency, develop SPC methods, perform statistical analyses, and ensure regulatory compliance. Lead development and optimization of manufacturing processes for transfer to operations.

Ensure suppliers deliver compliant parts and services by qualifying suppliers, conducting audits, implementing inspection and measurement plans, resolving supplier issues, supporting NPD and product transfers, and applying quality tools like CAPA, FMEA, and statistical sampling.

Lead change control, support deviation investigations and CAPA, conduct risk and microbial impact assessments, oversee commercial campaign readiness, develop training and SOPs, provide on-floor troubleshooting and testing (functional/water/process challenge), improve MBRs and processes, and act as SME for technical problem-solving and continuous improvement in GMP biomanufacturing.

Support product transfers and process validation through commercial release. Perform compliant validation and documentation for quality IT systems, including system administration and configuration. Coordinate with clients, developers, and operations, track validation status, and ensure procedures meet federal and international regulatory requirements. Maintain awareness of regulatory changes and audit expectations.

Lead engineering efforts for process optimization, equipment design, troubleshooting, and validation across manufacturing, pilot plant, and capital projects in pharma/medical device environments. Coordinate multidisciplinary teams, consultants, and project budgets while supervising a small engineering staff.