Manager, Quality Management Systems (Genomics)

Location: South San Francisco, California, USA

Base salary: $150,000–$175,000 USD per year, plus bonus, equity, and benefits.

Company

hirify.global synthesizes genes from scratch using a silicon-based DNA synthesis platform for applications in healthcare, agriculture, industrial chemicals, and data storage.

What you will do

• Implement and maintain QMS procedures compliant with ISO 13485:2016 and applicable regulations across product lines.
• Own internal and external audit programs, including scheduling, execution, and resolution of nonconformities.
• Manage local and global audit teams and lead quality assurance initiatives focused on compliance, audits, and training.
• Develop and manage quality training curricula, assignments, and completion tracking across all disciplines.
• Support product and software development lifecycles through design controls, monitoring and measurement systems, and continuous improvement.
• Ensure supplier quality objectives are met and mentor QA team members on QMS, ISO 13485, and regulatory compliance.

Requirements

• Bachelor’s degree in engineering, physical or life sciences, or a related field; a master’s degree is preferred.
• 7+ years of experience in the medical device or biotechnology industry, with strong QMS and ISO 13485 expertise.
• Experience developing and implementing QMS procedures and conducting internal and external audits.
• Working knowledge of genomics, regulatory compliance, product development lifecycles, and commercialization programs.
• Hands-on experience with QMS management software.
• Strong supervisory, organizational, analytical, problem-solving, communication, collaboration, and leadership skills.

Nice to have

• Genomics industry experience.
• Experience with FDA regulations for medical devices and IVDs, EU IVDR, or GMP requirements.
• Deep knowledge of risk management and design controls.
• Six Sigma or another quality improvement methodology.

Culture & Benefits

• Work in a fast-paced genomics and life sciences environment.
• Eligibility for bonus and equity compensation.
• Generous benefits package.
• Equal employment opportunity for all employees and applicants.