Associate Director, Quality (Medical Devices)

Location: Hayward, California, United States. Applicants must be authorized to work for any employer in the U.S.; visa sponsorship is not available.

Salary: $160,000–$220,000 annually, plus potential discretionary bonuses.

Company

hirify.global develops and manufactures healthcare products focused on improving patient care and sustaining lives.

What you will do

• Serve as the plant-level Management Representative for Quality and lead the Quality organization within a mid-to-large manufacturing facility.
• Develop, deploy, and maintain quality systems covering Management Review, CAPA, Design Controls, Process Controls, and product release.
• Oversee batch review, device conformity verification, Post-Market Surveillance, and MDR vigilance reporting.
• Maintain product quality and regulatory compliance while managing inspections, audits, customer interactions, and regulatory agency communications.
• Lead continuous improvement, technology transfer support, acquisition quality assessments, and cross-functional global initiatives.
• Manage the Quality budget and lead coaching, training, performance management, development, and succession planning.

Requirements

• Bachelor’s degree in Science, Engineering, or a related technical discipline; an advanced degree is preferred.
• At least 10 years of experience in Quality, Manufacturing, or a related field within the medical products industry.
• At least 7 years of management experience, including leadership of large teams in complex regulated environments.
• Extensive knowledge of medical device and therapeutics regulations, quality systems, regulatory standards, and industry requirements.
• Experience with risk management, validation, analytics, microbiology, GMP-regulated environments, and technology transfer.
• Ability and willingness to work in ISO 7 and ISO 8 cleanroom manufacturing environments, including required gowning procedures.

Culture & Benefits

• Mission-driven environment focused on saving and sustaining lives.
• Medical and dental coverage beginning on the first day for eligible roles.
• Life, disability, accident, and business travel insurance.
• 401(k) retirement plan with employee contributions and company matching, plus an Employee Stock Purchase Plan.
• Paid holidays, 20–35 days of paid time off based on tenure, family and medical leave, and paid parental leave.
• Educational assistance, commuting benefits, childcare benefits, employee discounts, and employee assistance programs.