Manager

Job Description

Responsibilities

Design Control Process Management

• Develop, establish, implement, and continuously improve design control processes governing
• Ensure design control processes meet applicable FDA and ISO requirements and are appropriately integrated into product-development activities.
• Translate quality and regulatory requirements into clear, scalable, and executable procedures, tools, templates, and working practices.
• Evaluate the effectiveness of design control processes and recommend updates based on product-development needs, quality data, regulatory expectations, audit observations, and industry best practices.
• Create a scalable implementation plan for deployment of new and updated design control requirements across new product development, sustaining engineering, remediation, and product-change activities.

Design History File and Traceability

• Establish and maintain processes and SOPs that support complete, accurate, and audit-ready Design History Files from user needs through design validation.
• Partner with project teams to identify and resolve documentation, traceability, and design control gaps.

Quality Assurance and Compliance

• Plan, implement, and manage quality assurance protocols and methods supporting medical-device design, development, transfer, and production readiness.
• Ensure processes align with applicable internal quality standards and external regulatory requirements for products intended for worldwide distribution.
• Review quality, development, and production information to identify trends, recurring issues, and opportunities to improve quality standards and procedures.
• Support compliance with applicable FDA requirements, ISO 13485, ISO 14971, and other relevant product-development standards.
• Apply knowledge of 21 CFR Part 11, IEC 60601, IEC 62366, and IEC 62304, as applicable, to product-development projects and design control processes.

Risk Management

• Lead or facilitate product and design risk-management activities, including hazard analyses and Design Failure Mode and Effects Analyses.
• Ensure risk-management activities are appropriately linked to design requirements, verification, validation, risk controls, and post-control risk evaluation.
• Partner with technical and quality teams to identify, document, evaluate, and mitigate product and process risks.
• Support alignment between design control and risk-management processes throughout the product lifecycle.

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