Quality/System Engineer

Hired by Matrix, Inc is a certified technology solutions and compliance consulting services company, and they are seeking a Quality/System Engineer. The role involves leading design control processes, ensuring compliance with FDA regulations, and collaborating with cross-functional teams to maintain product documentation and traceability.

Responsibilities:

• Lead efforts to develop and implement robust design control processes for new and existing products, ensuring compliance with FDA regulations (21 CFR 820), ISO 13485, and other relevant industry standards
• Establish and maintain traceability throughout the design and development phases, ensuring that user needs, design inputs, and verification requirements are fully traced and documented
• Work cross-functionally to trace user needs to design validation, ensuring that final products meet both the defined requirements and user expectations. This includes the development of comprehensive Design History Files (DHF) and validation documentation
• Collaborate with teams to ensure that all products undergo thorough design verification and design validation processes, providing evidence that the product meets the necessary specifications
• Work closely with other engineering disciplines, such as hardware, software, and quality teams, to ensure a seamless integration of design controls and traceability throughout the product lifecycle
• Prepare and maintain detailed documentation for design control processes, ensuring all deliverables are compliant with internal and regulatory standards. Provide updates to leadership and stakeholders on project status, risks, and timelines
• Identify areas for process improvements in design control and traceability methods and implement changes that enhance the efficiency and effectiveness of product development

Requirements:

• 5 - 8 years of experience in quality or system engineering within a regulated environment, preferably in medical devices or other highly regulated industries
• Strong experience in implementing and managing design controls processes, including traceability, user needs, and design verification/validation
• Proven ability to ensure full traceability from user needs to design validation and manage product documentation accordingly
• In-depth knowledge of FDA regulations (21 CFR 820), ISO 13485, and other applicable standards for medical devices
• Strong communication and interpersonal skills, with experience working effectively in cross-functional teams
• Strong verbal and written communication in English