Principal Medical Device Design QA Lead

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

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,