Quality Engineering & Compliance is a critical component of regulated manufacturing, ensuring that products, processes, equipment, and documentation align with global regulatory requirements and internal quality standards. Fusion provides comprehensive quality engineering support for life sciences, pharmaceuticals, medical devices, food and beverage, automotive, aerospace, and general manufacturing industries.
Our approach integrates engineering rigor with regulatory discipline—balancing speed, operational efficiency, and audit readiness.
We help clients maintain a robust Quality Management System (QMS), reduce compliance risk, prevent deviations, and ensure their operations remain inspection-ready at all times.
Fusion supports the design, implementation, and maintenance of Quality Management Systems compliant with ISO, FDA, and industry-specific frameworks.
We develop and maintain core QMS components including:
Our specialists ensure traceability between requirements, process documentation, testing outputs, and regulatory filing requirements.
We work with cross-functional teams—engineering, operations, supply chain, R&D—to ensure quality systems accurately reflect current manufacturing processes and regulatory expectations.
Fusion helps clients meet global regulatory requirements applicable to their industries. This includes compliance with:
Life Sciences & Pharmaceuticals:
General & Industrial Manufacturing:
Fusion engineers and quality specialists interpret requirements, map them to operational processes, and develop appropriate control measures, ensuring documentation, testing, and process controls align with regulatory expectations.
Risk mitigation is central to regulated engineering. Fusion facilitates and executes structured risk assessments across the product and process lifecycle.
Our risk management scope includes:
We document failure modes, identify severity/probability rankings, recommend mitigations, link actions to CAPA, and ensure risk-based decision-making drives validation scope, control plans, inspection criteria, and ongoing process monitoring.
Fusion manages end-to-end deviation handling and CAPA workflows that strengthen operational reliability.
This includes:
Our teams ensure all deviations and CAPAs are documented, addressed, and closed according to quality timelines.
We help reduce recurrence, improve process stability, and support audit readiness.
Change Control ensures modifications to equipment, systems, processes, or documentation are properly assessed, approved, tested, and implemented.
Fusion supports:
Changes are always linked to risk assessments and validation activities to prevent non-compliance and maintain process integrity.
Suppliers and contractors influence product quality directly. Fusion enhances supplier oversight by:
For high-risk or regulated supply chains (medical devices, pharma equipment), we embed engineers to monitor supplier performance and ensure compliance with quality and regulatory requirements.
Fusion prepares clients for regulatory inspections and internal audits by strengthening documentation, resolving gaps, and training teams in audit response.
We support:
During audits, Fusion provides real-time support, documentation retrieval, narrative framing, and post-audit action planning.
We provide on-site Quality Engineers who support daily operations—ensuring production meets specification, quality escapes are minimized, and process stability is maintained.
Their responsibilities include:
This function is essential for manufacturing environments that run 24/7 or require continuous monitoring to maintain compliance and yield.
Fusion ensures data integrity across paper-based and digital systems (ALCOA+ principles).We review batch records, logbooks, audit trails, test reports, and engineering change orders for accuracy, traceability, and completeness.
This protects clients from:
We help establish data review processes, electronic record controls, and documentation standards that align with FDA and ISO requirements.
Organizations rely on Fusion’s Quality Engineering & Compliance teams to achieve:
Fusion integrates deeply with engineering, operations, and quality teams to deliver consistent, compliant outcomes in complex, regulated environments.
We provide capability, problem-solving, and services — with speed and cost-efficiency at the core
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