Principal Design Quality Assurance Engineer

Alpfa Medical, Inc.; Palo Alto (CA); On-site; USD 150,000 - 210,000; Full time

Job summary

Alpfa Medical, Inc. in Palo Alto is seeking a Principal Design Quality Assurance Engineer to lead quality initiatives across the medical device product development lifecycle.

You will partner with R&D, Regulatory and Manufacturing to ensure safety, effectiveness, and compliance with ISO 13485, FDA 21 CFR Part 820, ISO 14971, ISO 10993-1 and other applicable standards. Responsibilities include maintaining design history files, supporting regulatory submissions, leading risk management activities,

Qualifications

• Experience with QMS and regulatory standards (ISO 13485, FDA 21 CFR Part 820, ISO 14971) is required.
• Strong leadership and cross-functional collaboration skills.
• Ability to drive design controls and risk management across the product lifecycle.

Responsibilities

• Lead design quality assurance activities throughout the product lifecycle—from concept to commercialization.
• Maintain DHFs and ensure documentation is audit-ready, including requirements, V&V protocols and reports.
• Support regulatory submissions with quality and risk management documentation; participate in internal and external audits.

Job description

Principal Design Quality Assurance Engineer is responsible for driving quality initiatives to support product development and lifecycle management. This role is critical to ensuring that products meet all applicable regulatory and quality standards from concept through commercialization. This role will work closely with R&D, Regulatory, and Manufacturing teams to ensure product safety, effectiveness, and compliance with ISO 13485, FDA 21 CFR Part 820, ISO 14971, ISO 10993-1, IEC 60601-1, IEC 62304, IEC 62366 and other applicable regulations or standards. This role demands extensive experience in design assurance for medical devices, strong leadership, and the ability to work with cross-functional teams.

Duties/Responsibilities:

• Assure product and process quality in accordance with QMS & applicable regulations & quality principles.
• Ensure product development processes comply with ISO 13485, FDA 21 CFR Part 820, ISO 14971, ISO 10993-1, IEC 60601-1, IEC 62304, IEC 62366 and other applicable regulations or standards.
• Serve as the primary quality representative for product development teams
• Lead design quality assurance activities throughout the product lifecycle - from concept, development, verification/validation, to commercialization.
• Lead or support risk management activities (e.g., FMEA, hazard analysis) throughout the product lifecycle. Develop risk management strategies and ensure that risk management documentation is up-to-date and in compliance with regulatory requirements.
• Maintain DHFs and ensure documentation is audit ready.
• Support regulatory submissions by providing required quality and risk management documentation.
• Lead cross-functional discussions to resolve quality issues and improve product design.
• Support complaint investigation, NCRs, CAPAs, and post-market activities to ensure ongoing product quality and compliance.
• Evaluate engineering change orders to ensure continued compliance and product quality.
• Present quality status, risk updates, and design control metrics during project review.
• Communicate quality risks, decisions, and recommendations to leadership and project teams.
• Participate in internal and external audits as required.
• Lead or support investigations, root cause analysis, and continuous improvement initiatives related to product design.
• Ensure accurate, detailed, and compliant documentation related to design control processes. Review and approve DHF documents, including requirements specification, V&V protocols and reports, and risk management files.
• Other responsibilities as assigned by manager.