Design Control Process Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop, establish, execute, and continuously enhance processes for medical-device design control.

• Ensure that design control processes align with FDA and ISO standards and are integrated into product development activities.

• Convert quality and regulatory requirements into procedures, tools, templates, and operational practices.

• Assess process effectiveness and suggest updates based on product development needs, quality data, regulatory expectations, audit findings, and industry best practices.

• Formulate implementation strategies for new and revised design control requirements in new product development, sustaining engineering, remediation, and product change initiatives.

• Establish and uphold Standard Operating Procedures (SOPs) that support complete, accurate, and audit-ready Design History Files.

• Collaborate with project teams to address documentation, traceability, and design control discrepancies.

• Plan, execute, and manage quality assurance protocols for medical-device design, development, transfer, and production readiness.

• Analyze quality, development, and production data to detect trends and opportunities for improvement.

• Aid in maintaining compliance with FDA, ISO 13485, ISO 14971, 21 CFR Part 11, IEC 60601, IEC 62366, and IEC 62304.

• Lead or facilitate hazard analyses and Design Failure Mode and Effects Analyses.

• Connect risk management activities to design requirements, verification, validation, risk controls, and post-control risk evaluation.

• Identify, document, evaluate, and mitigate risks associated with products and processes.

• Work collaboratively with R&D, Quality, Regulatory Affairs, Manufacturing, and other functional partners.

• Act as a trusted advisor and advocate for best practices in design control and design assurance.

• Influence cross-functional teams to ensure consistent adherence to established processes.

• Facilitate the resolution of conflicting quality, regulatory, technical, and operational requirements.

⛳️ Requirements

• Bachelor’s degree in Engineering or a related technical field.

• Over 12 years of experience in medical device Quality Assurance or Design Assurance.

• Proven knowledge of FDA 21 CFR 820, 21 CFR Part 11, ISO 13485, and ISO 14971.

• Familiarity with IEC 60601, IEC 62366, and IEC 62304.

• Experience with Quality Management System (QMS) software such as MasterControl or Veeva Vault.

• Knowledge of Document Control systems.

• Proven ability to influence cross-functional teams and ensure adherence to design control processes.

• Strong history of collaboration across Quality, Regulatory, R&D, and Manufacturing departments.

• Ability to act as a trusted advisor and advocate for best practices in design control.

• Willingness to travel domestically and internationally as required.

🏝️ Benefits

• Opportunity for skill and career advancement.

• Reasonable accommodations provided for qualified individuals with disabilities during the job application process.