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.

Lead supplier quality activities to ensure delivered parts, materials, and services meet regulatory and company quality standards. Qualify and audit suppliers, monitor part lifecycle, support Pre‑Market Quality Engineering for NPD, define receiving inspection/test method validation, collaborate on control plans and approved supplier lists, resolve supplier issues, and drive continuous improvement. Role requires travel to contract manufacturers and suppliers.

Lead supplier quality activities for medical device/pharma components: qualify and audit suppliers, monitor parts through manufacturing, support NPD with quality compliance, define inspection/test methods, drive continuous improvement, and travel to contract manufacturers to resolve supplier issues.

Execute process validation (PV) and equipment qualification (CSV) for pharmaceutical manufacturing; provide technical and sustaining engineering support; recommend and implement process/equipment improvements; develop SPC and measurement systems; lead manufacturing process innovation and ensure regulatory compliance.

Provide technical and sustaining engineering support for medical device/pharma manufacturing. Recommend and implement equipment and process modifications, develop and optimize manufacturing processes, conduct statistical analysis and process control, support transfers to manufacturing, ensure regulatory compliance, and collaborate with cross-functional teams to improve production yield and efficiency.

Design and optimize manufacturing processes, layouts, and sequences for new product introductions. Lead equipment validation (IQ/OQ/PQ), process validation lifecycle, SOP and change-control documentation, and support line implementation and special builds. Inspect equipment performance, develop statistical process control techniques, and support computer/software validation and MES activities.

Lead engineering efforts for process optimization, troubleshooting, system/facility modifications, and cross-functional projects in pharmaceutical manufacturing. Oversee small engineering teams, coordinate consultants, develop budgets, policies, and validation documentation, and provide technical guidance on inspection equipment and reliability improvements.

Lead end-to-end program management for site MES deployments, ensuring alignment to business priorities, compliance, schedule, budget, resource management, integrations (ERP, LMS, equipment), go-live, hypercare, training, and change management to minimize production disruption.

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

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

Manage operational aspects of product and service development projects across cross-functional teams. Monitor project status, schedules, budgets, and risks from initiation through delivery. Develop progress-monitoring mechanisms, resolve issues, prepare status reports, and lead interventions to meet productivity, quality, and client-satisfaction goals.

Support manufacturing for medical devices through change control, equipment commissioning/qualification, process and computer system validation, packaging system design per ISO 11607/ASTM/ISTA, troubleshooting, root cause investigations, and technical/sustaining engineering to improve processes and ensure quality.

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 improve pharmaceutical/medical-device manufacturing processes and layouts, perform equipment and process validation, investigate root causes, apply statistical techniques, and provide technical support to ensure product quality and production efficiency.

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 improve manufacturing processes and plant layouts, specify fabrication and inspection procedures, validate equipment and software, analyze machinery performance, perform root cause investigations, and apply statistical process control to ensure product quality in pharmaceutical/medical device manufacturing.

Support medical device manufacturing through change control, equipment commissioning/qualification, process and computer system validation, packaging system design per ISO 11607 standards, troubleshooting, process improvements, investigations/root-cause analysis, and technical documentation across manufacturing, packaging, and lab equipment.

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.

Lead engineering efforts for process optimization, equipment design, troubleshooting, and large system/facility modifications in pharmaceutical and medical device manufacturing. Coordinate cross-functional teams, vendors, and project managers to deliver projects on schedule and within budget. Develop policies, budgets, and standard design documents; supervise small engineering teams and serve as a peer-recognized technical specialist.

Lead and approve GMP and manufacturing process documentation, validation protocols (PPQ, cleaning), deviations, investigations, CAPAs, site audits, NPI, and quality programs to ensure cGMP compliance in biopharma manufacturing.